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Control, Plasma, Abnormal

FDA product code GGC · 40 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: 1977-02-18 – 2011-04-05

GGC 2011-04-05

HEMOSIL LA POSITIVE CONTROL

Applicant Instrumentation Laboratory CO

K number K102552

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GGC 2010-12-15

SPECIALTY ASSAYED CONTROL-2

Applicant Helena Laboratories

K number K100103

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GGC 2007-03-16

PLASMACON N, PLASMACON L-1, PLASMACON L-2

Applicant R2 Diagnostics, Inc.

K number K062306

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GGC 2006-07-28

STA - CONTROL LA 1+2

Applicant Diagnostica Stago, Inc.

K number K061803

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GGC 2003-11-03

CRYOCHECK WEAK LUPUS POSITIVE CONTROL

Applicant Precision Biologic

K number K032804

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GGC 2002-11-01

CONTROL PLASMA P

Applicant Dade Behring, Inc.

K number K023312

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GGC 2002-04-15

LYPHOCHEK HEMOSTASIS, MODELS 798, 799

Applicant Bio-Rad

K number K020878

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GGC 2002-02-06

SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL

Applicant Sigma Diagnostics, Inc.

K number K020109

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GGC 2001-08-21

K-ASSAY D-DIMER CONTROLS

Applicant Kamiya Biomedical Co.

K number K012422

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GGC 2001-03-01

SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217

Applicant Sigma Diagnostics, Inc.

K number K003329

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GGC 2000-02-16

GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05

Applicant Gradipore , Ltd.

K number K993332

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GGC 1998-12-01

COAGULATION CONTROL LEVEL 3 (ABNORMAL)

Applicant Pacific Hemostasis

K number K984131

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GGC 1998-12-01

COAGULATION CONTROL LEVEL 2 (ABNORMAL)

Applicant Pacific Hemostasis

K number K984130

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GGC 1996-05-24

LA POSITIVE CONTROL PLASMA

Applicant Medical Diagnostic Technologies, Inc.

K number K961370

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GGC 1996-01-31

AT-III CONTROL PLASMA KIT

Applicant American Bioproducts Co.

K number K955040

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GGC 1995-11-06

CRYO CHECK LUPUS PLASMA

Applicant Precision Biologicals, Inc.

K number K952623

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GGC 1995-10-30

CRYO CHECK ABNORMAL REFERENCE CHECK I & II

Applicant Precision Biologicals, Inc.

K number K952624

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GGC 1995-10-05

POSITIVE LUPUS ANTICOAGULANT PLASMA

Applicant George King Bio-Medical, Inc.

K number K945856

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GGC 1995-09-21

STA-COAG CONTROL [P] PLUS KIT

Applicant American Bioproducts Co.

K number K952338

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GGC 1994-11-21

SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302

Applicant Helena Laboratories

K number K941872

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GGC 1994-03-22

BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL

Applicant Biomerieux Vitek, Inc.

K number K930267

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GGC 1994-02-22

CONTROL PLASMA U

Applicant Behring Diagnostics, Inc.

K number K924402

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GGC 1994-02-22

PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)

Applicant Behring Diagnostics, Inc.

K number K924401

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GGC 1993-05-20

FACTOR CONTROL [P]

Applicant American Bioproducts Co.

K number K930959

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GGC 1993-04-27

COAG-CONTROL

Applicant American Bioproducts Co.

K number K930923

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GGC 1992-12-01

CONTROL PLASMA P

Applicant Behring Diagnostics, Inc.

K number K924405

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GGC 1992-06-09

AVK CONTROL I & II

Applicant American Bioproducts Co.

K number K921665

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GGC 1991-06-11

DADE(R) PROTEIN C ABNORMAL CONTRAL

Applicant Baxter Healthcare Corp

K number K911885

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GGC 1990-10-22

COAGULATION REFERENCE PLASMA, ABNORMAL

Applicant Medi-Tech, Inc.

K number K904073

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GGC 1990-04-11

ORTHO ABNORMAL PROTEIN C CONTROL PLASMA

Applicant Ortho Diagnostic Systems, Inc.

K number K901233

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GGC 1990-03-27

HEPARIN CONTROL PLASMA, FOR USE IN APTT

Applicant Medical Diagnostic Technologies, Inc.

K number K900782

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GGC 1989-10-06

ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2)

Applicant Medical Diagnostic Technologies, Inc.

K number K895261

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GGC 1989-10-06

ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1)

Applicant Medical Diagnostic Technologies, Inc.

K number K895260

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GGC 1989-08-03

ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III

Applicant Analytical Control Systems, Inc.

K number K894425

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GGC 1989-07-25

ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III

Applicant Analytical Control Systems, Inc.

K number K894338

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GGC 1989-07-25

ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II

Applicant Analytical Control Systems, Inc.

K number K893971

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GGC 1989-07-25

ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II

Applicant Analytical Control Systems, Inc.

K number K893970

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GGC 1988-05-06

CLP ABNORMAL COAGULATION CONTROL

Applicant Creative Laboratory Products, Inc.

K number K881510

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GGC 1987-12-11

HERPES 1 AND 2 MICROASSAYS

Applicant Diamedix Corp.

K number K871420

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GGC 1977-02-18

HPC TM (HEPARINIZED PLASMA CONTROL)

Applicant Bio/Data Corp.

K number K770188

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