Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Plasma, Coagulation Control

FDA product code GGN · 97 cleared devices

Class 2 Hematology

Regulation: 21 CFR 864.5425
Review panel: HE
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-08-22 – 2017-06-21

GGN 2017-06-21

VALIDATE D-Dimer Calibration Verification / Linearity Test Kit

Applicant Maine Standards Company, LLC

K number K170864

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GGN 2017-03-16

VALIDATE Heparin Calibration Verification/Linearity Test Kit

Applicant Maine Standards Company, LLC

K number K163498

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GGN 2017-02-23

George King Coumadin Plasma

Applicant George King Bio-Medical, Inc.

K number K161316

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GGN 2017-01-05

VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit

Applicant Maine Standards Company, LLC

K number K162705

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GGN 2016-06-03

VALIDATE D-Dimer Calibration Verification/Linearity Test Kit

Applicant Maine Standards Company, LLC

K number K152961

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GGN 2016-03-06

VisuCon-F Low Fibrinogen Control Plasma

Applicant Affinity Biologicals, Inc.

K number K150144

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GGN 2013-07-03

DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC

Applicant International Technidyne Corp.

K number K120977

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GGN 2013-05-31

I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2

Applicant Cliniqa Corporation

K number K120900

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GGN 2013-03-14

STA- COAG CONTROL (N+ABN) PLUS

Applicant Diagnostica Stago, Inc.

K number K120014

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GGN 2012-01-04

HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL

Applicant Instrumentation Laboratory CO

K number K113211

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GGN 2011-10-20

VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN

Applicant Affinity Biologicals, Inc.

K number K110432

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GGN 2011-06-23

AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5

Applicant Aalto Scientific, Ltd.

K number K100716

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GGN 2010-12-20

PT-MULTI-CALIBRATOR, MODEL OPAT07

Applicant Dade Behring, Inc.

K number K093848

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GGN 2010-12-03

CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL

Applicant Medtronic, Inc.

K number K103314

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GGN 2010-12-01

HEPARIN ASSAY CONTROLS

Applicant Medtronic, Inc.

K number K103313

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GGN 2009-10-28

VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA

Applicant Affinity Biologicals, Inc.

K number K091284

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GGN 2009-10-09

HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)

Applicant Instrumentation Laboratory CO

K number K090563

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GGN 2008-12-19

HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED

Applicant Instrumentation Laboratory CO

K number K082859

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GGN 2007-06-26

I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02

Applicant Bio-Rad, Diagnostics Grp.

K number K071319

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GGN 2007-03-01

TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS

Applicant Biosite Incorporated

K number K062840

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GGN 2007-01-29

COAGUCHEK XS PT CONTROLS

Applicant Roche Diagnostics Corp.

K number K063823

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GGN 2006-01-04

HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL

Applicant Akers Biosciences, Inc.

K number K052697

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GGN 2005-12-23

BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR

Applicant Hyphen Biomed

K number K051472

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GGN 2005-06-29

TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS

Applicant Biosite Incorporated

K number K050799

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GGN 2005-03-17

BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR

Applicant Hyphen Biomed

K number K043451

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GGN 2004-12-22

PEFAKIT APC-R FACTOR V LEIDEN CONTROLS

Applicant Pentapharm , Ltd.

K number K042760

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GGN 2004-12-01

CONTROL PLASMA N, PROC CONTROL PLASMA

Applicant Dade Behring, Inc.

K number K042333

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GGN 2004-10-21

CONTROL PLASMA N AND CONTROL PLASMA P

Applicant Dade Behring, Inc.

K number K042209

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GGN 2004-10-18

PURPLE/BLACK HEPARIN ASSAY CONTROL

Applicant Medtronic Vascular

K number K042206

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GGN 2004-10-18

HEPARINASE HR ACT CONTROL, MODEL 550-12

Applicant Medtronic Vascular

K number K042175

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GGN 2004-02-27

LYPHOCHEK HEMOSTASIS CONTROL

Applicant Bio-Rad

K number K040275

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GGN 2003-09-17

LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743

Applicant Bio-Rad

K number K032611

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GGN 2003-08-08

LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3

Applicant Bio-Rad

K number K032017

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GGN 2003-06-06

CONTROL PLASMA LMW HEPARIN

Applicant Instrumentation Laboratory CO

K number K030965

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GGN 2003-02-24

LIQUICHEK D-DIMER CONTROL, MODEL 356, 357

Applicant Bio-Rad

K number K030182

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GGN 2002-07-23

VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL

Applicant Vital Scientific N.V.

K number K022046

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GGN 2002-05-16

HEMOSIL HIGH ABNORMAL CONTROL ASSAYED

Applicant Instrumentation Laboratory CO

K number K021024

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GGN 2002-05-14

HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)

Applicant Instrumentation Laboratory CO

K number K021023

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GGN 2002-05-14

HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)

Applicant Instrumentation Laboratory CO

K number K021022

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GGN 2001-09-18

LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783

Applicant Bio-Rad

K number K012722

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GGN 2001-09-07

PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560

Applicant Fisher Diagnostics

K number K010750

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GGN 2001-04-09

STA -CALIBRATOR HBPM/LMWH KIT

Applicant Diagnostica Stago, Inc.

K number K010350

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GGN 2001-04-09

STA-QUALITY HBPM/LMWH KIT

Applicant Diagnostica Stago, Inc.

K number K010324

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GGN 2000-03-24

THROMBOSTRATE CONTROL PLASMAS

Applicant Pacific Hemostasis

K number K000679

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GGN 2000-02-15

HMP CONTROLS (TAS) RAPIDPOINT

Applicant Cardiovascular Diagnostics, Inc.

K number K994159

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GGN 1999-12-20

POLLER CALIBRANTS

Applicant European Concerted Action on Anticoagulation

K number K991439

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GGN 1999-11-22

CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3

Applicant Medical Analysis Systems, Inc.

K number K992829

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GGN 1999-08-26

HEPARIN CONTROL PLASMA LEVEL 2

Applicant Pacific Hemostasis

K number K992279

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GGN 1999-08-26

HEPARIN CONTROL PLASMA LEVEL 1

Applicant Pacific Hemostasis

K number K992278

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GGN 1999-04-21

LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789

Applicant Bio-Rad

K number K990858

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GGN 1998-06-15

I-STAT COAGULATION CONTROL SET

Applicant Biopool Intl., Inc.

K number K981752

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GGN 1998-04-29

SIGMA DIAGNOSTICS ACCUCLOT CONTROL III

Applicant Sigma Diagnostics, Inc.

K number K981255

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GGN 1998-04-29

SIGMA DIAGNOSTICS ACCUCLOT CONTROL II

Applicant Sigma Diagnostics, Inc.

K number K981254

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GGN 1998-04-29

SIGMA DIAGNOSTICS ACCUCLOT CONTROL I

Applicant Sigma Diagnostics, Inc.

K number K981248

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GGN 1998-04-27

THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS

Applicant Cardiovascular Diagnostics, Inc.

K number K981178

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GGN 1998-04-16

AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2

Applicant Avocet Medical, Inc.

K number K980982

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GGN 1997-08-29

CRYO CHECK INR VALIDATION SET

Applicant Precision Biologicals, Inc.

K number K971219

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GGN 1997-08-19

CRYO CHECK APC RESISTANT PLASMA

Applicant Precision Biologicals, Inc.

K number K971222

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GGN 1997-06-26

STA LIATEST CONTROL [N]+[P] KIT

Applicant American Bioproducts Co.

K number K964716

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GGN 1997-06-17

COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0

Applicant Pacific Hemostasis

K number K971428

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GGN 1997-05-29

TAS PT-NCTEST CONTROLS

Applicant Cardiovascular Diagnostics, Inc.

K number K971748

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GGN 1997-02-20

LYPHOCHEK COAGULATION CONTROL

Applicant Bio-Rad

K number K964963

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GGN 1996-07-23

STA - VWF CONTROL [N]+[P] KIT

Applicant American Bioproducts Co.

K number K962674

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GGN 1996-06-05

TAS A PTT TEST CONTROLS

Applicant Cardiovascular Diagnostics, Inc.

K number K961189

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GGN 1996-05-30

TAS HMT CONTROLS

Applicant Cardiovascular Diagnostics, Inc.

K number K960234

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GGN 1996-05-30

BEHRING COAGULATION TIMER

Applicant Behring Diagnostics, Inc.

K number K955278

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GGN 1996-03-11

PORCINE FACTOR VIII;C REAGENT

Applicant Helena Laboratories

K number K952321

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GGN 1996-01-03

CRYO CHECK LOW FIBRINOGEN CONTROL

Applicant Precision Biologicals, Inc.

K number K951823

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GGN 1995-10-30

CRYO CHECK NORMAL HUMAN REFERENCE PLASMA

Applicant Precision Biologicals, Inc.

K number K952622

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GGN 1995-10-24

A-FACT, ABNORMAL FACTOR ASSAY CONTROL

Applicant George King Bio-Medical, Inc.

K number K945855

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GGN 1995-10-24

B-FACT, BORDERLINE FACTOR ASSAY CONTROL

Applicant George King Bio-Medical, Inc.

K number K945854

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GGN 1995-05-11

ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL

Applicant Ortho Diagnostic Systems, Inc.

K number K940209

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GGN 1995-03-21

STA SYSTEM CONTROL [N] + [P] KIT

Applicant American Bioproducts Co.

K number K943518

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GGN 1995-03-15

ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II

Applicant International Technidyne Corp.

K number K944691

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GGN 1994-09-14

SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)

Applicant Helena Laboratories

K number K941860

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GGN 1994-03-22

COAGULATION A.R.P.

Applicant Helena Laboratories

K number K933277

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GGN 1993-02-25

CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM

Applicant Precision Biologicals, Inc.

K number K922887

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GGN 1992-12-01

CLIBRATION PLASMAS

Applicant Behring Diagnostics, Inc.

K number K924404

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GGN 1992-10-26

COAG-CONTROL [N] KIT

Applicant American Bioproducts Co.

K number K922174

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GGN 1992-06-09

THROMBO-CALIBRATOR KIT

Applicant American Bioproducts Co.

K number K921344

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GGN 1992-03-04

COAGULATION ARPR,CAT.NO.5185

Applicant Helena Laboratories

K number K914949

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GGN 1991-08-22

ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED

Applicant Helena Laboratories

K number K911777

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GGN 1991-02-11

AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183

Applicant Helena Laboratories

K number K905673

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GGN 1990-07-26

COAGULATION CONTROL, LEVEL III

Applicant Sigma Chemical Co.

K number K902363

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GGN 1990-07-26

COAGULATION CONTROL, LEVEL II

Applicant Sigma Chemical Co.

K number K902362

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GGN 1990-07-26

COAGULATION CONTROL, LEVEL I

Applicant Sigma Chemical Co.

K number K902361

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GGN 1990-07-03

ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA

Applicant Ortho Diagnostic Systems, Inc.

K number K902210

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GGN 1990-01-25

ROCKET REFERENCE PLASMA, CAT NO. 5188

Applicant Helena Laboratories

K number K900019

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GGN 1989-02-02

DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO

Applicant Baxter Healthcare Corp

K number K884901

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GGN 1989-01-30

COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL)

Applicant Precision Biologicals, Inc.

K number K884854

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GGN 1988-08-30

HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II

Applicant International Technidyne Corp.

K number K882481

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GGN 1988-08-30

HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II

Applicant International Technidyne Corp.

K number K882480

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GGN 1988-05-02

VERIFY(R) REFERENCE PLASMA

Applicant Organon Teknika Corp.

K number K881348

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GGN 1988-02-19

CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER

Applicant Hemotec, Inc.

K number K880302

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GGN 1984-04-23

DIACELIN

Applicant Diatech, Inc.

K number K840288

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GGN 1984-02-03

CONTACT-K APTT REAGENT

Applicant Pacific Hemostasis

K number K834086

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GGN 1977-08-22

CI-TROL COAGULATION CONTROLS II & III

Applicant Dade, Baxter Travenol Diagnostics, Inc.

K number K771346

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