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Activated Partial Thromboplastin

FDA product code GFO · 52 cleared devices

Class 2 Hematology

Regulation: 21 CFR 864.7925
Review panel: HE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-03 – 2026-01-09

GFO 2026-01-09

HemosIL Silica Clotting Time

Applicant Instrumentation Laboratory (IL) Co.

K number K253957

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GFO 2020-10-23

Cryocheck Hex LA

Applicant Precision Biologic

K number K193556

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GFO 2016-03-16

HemosIL Silica Clotting Time

Applicant Instrumentation Laboratory CO

K number K160445

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GFO 2006-05-04

STA-CEPHASCREEN KIT

Applicant Diagnostica Stago, Inc.

K number K053111

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GFO 2006-04-13

HEMOSIL SYNTHASIL

Applicant Instrumentation Laboratory CO

K number K060688

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GFO 2005-03-30

HEMOSIL SILICA CLOTTING TIME

Applicant Instrumentation Laboratory CO

K number K050221

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GFO 2002-11-01

VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT

Applicant Vital Scientific N.V.

K number K022021

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GFO 2002-02-08

CARESIDE APTT

Applicant Careside Hemotology, Inc.

K number K014028

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GFO 2002-01-24

HEMOCHRON JR. CITRATE APTT CUVETTE

Applicant Itc, Inc.

K number K014008

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GFO 1999-12-06

SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334

Applicant Sigma Diagnostics, Inc.

K number K992712

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GFO 1999-12-06

SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094

Applicant Sigma Diagnostics, Inc.

K number K992711

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GFO 1997-11-20

HEMOCHRON CITRATE APTT

Applicant International Technidyne Corp.

K number K972831

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GFO 1997-11-04

IL TEST APTT-SP

Applicant Instrumentation Laboratory CO

K number K973306

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GFO 1997-03-07

SPECKTIN-LA TEST SET

Applicant Analytical Control Systems, Inc.

K number K961892

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GFO 1996-04-23

SYNTHAFAX APTT REAGENT

Applicant Ortho Diagnostic Systems, Inc.

K number K955638

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GFO 1996-04-19

PATHROMTIN SL

Applicant Behring Diagnostics, Inc.

K number K955450

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GFO 1995-11-30

SYNTHASIL APTT REAGENT

Applicant Ortho Diagnostic Systems, Inc.

K number K953981

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GFO 1994-12-02

APTT-ES

Applicant Helena Laboratories

K number K935169

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GFO 1993-12-06

APTT-ES REAGENT

Applicant Medical Diagnostic Technologies, Inc.

K number K934351

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GFO 1993-10-25

PATHROMTIN

Applicant Behring Diagnostics, Inc.

K number K932011

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GFO 1993-04-27

ACS APCT REAGENT, MODIFIED

Applicant Analytical Control Systems, Inc.

K number K926012

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GFO 1993-01-27

HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT

Applicant International Technidyne Corp.

K number K924637

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GFO 1993-01-14

HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT

Applicant International Technidyne Corp.

K number K924638

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GFO 1992-12-23

STACLOT LA TEST KIT

Applicant American Bioproducts Co.

K number K923731

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GFO 1992-10-19

PLATELIN L

Applicant Organon Teknika Corp.

K number K921396

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GFO 1992-08-18

ACS FREEZE-DRIED APTT REAGENT

Applicant Analytical Control Systems, Inc.

K number K921223

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GFO 1992-07-28

ACS APCT REAGENT

Applicant Analytical Control Systems, Inc.

K number K921118

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GFO 1992-02-14

ELLAGIC ACID APTT REAGENT

Applicant Helena Laboratories

K number K915418

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GFO 1992-02-11

HEMOCHRON ONESTEP APTT TEST

Applicant International Technidyne Corp.

K number K915344

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GFO 1991-07-17

HEMOCHRON(R) APTT, MODIFICATION

Applicant International Technidyne Corp.

K number K911994

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GFO 1991-01-25

ANTICARDIOLIPIN ANTIBODY TEST SYSTEM

Applicant Medical Innovations Corp.

K number K903531

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GFO 1991-01-14

THE THERATEST ACA TEST

Applicant Theratest Laboratories, Inc.

K number K905301

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GFO 1990-11-08

APTT REAGENT

Applicant Sigma Chemical Co.

K number K904341

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GFO 1990-08-06

ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST

Applicant Analytical Control Systems, Inc.

K number K902556

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GFO 1990-01-25

APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT

Applicant Medical Diagnostic Technologies, Inc.

K number K900049

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GFO 1989-12-01

ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)

Applicant Sigma Chemical Co.

K number K896545

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GFO 1989-10-06

APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT

Applicant Medical Diagnostic Technologies, Inc.

K number K895255

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GFO 1989-06-22

APTT BY HEMOCHRON(R)

Applicant Intensive Technology, Inc.

K number K892209

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GFO 1989-05-22

COAG-1 APTT TEST CARD

Applicant Cardiovascular Diagnostic Services

K number K891015

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GFO 1989-04-21

THROMBOSCREEN APTT REAGENT

Applicant Pacific Hemostasis

K number K891337

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GFO 1989-04-21

EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME

Applicant Elite Diagnostic , Ltd.

K number K890859

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GFO 1989-03-15

EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT

Applicant Elite Diagnostic , Ltd.

K number K890619

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GFO 1989-02-24

BIOTRACK APTT REAGENT CARTRIDGE

Applicant Biotrack, Inc.

K number K890052

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GFO 1989-01-30

APTT REAGENT

Applicant Precision Biologicals, Inc.

K number K884856

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GFO 1989-01-27

EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629

Applicant Em Diagnostic Systems, Inc.

K number K884702

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GFO 1988-12-28

KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT

Applicant King Diagnostics, Inc.

K number K884485

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GFO 1988-08-25

UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST

Applicant Sclavo, Inc.

K number K882325

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GFO 1988-03-23

CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST

Applicant Creative Laboratory Products, Inc.

K number K881068

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GFO 1982-04-26

ALUMINA SILICA-ACTIVATED PARTIAL THROM

Applicant Hyland Therapeutic Div., Travenol Laboratories

K number K820835

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GFO 1978-08-10

PLASMA COAGULATION CONT., ABNORMAL

Applicant Ortho Diagnostics, Inc.

K number K781104

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GFO 1977-01-10

HEPARIN CONTROL PLASMA

Applicant Hyland Therapeutic Div., Travenol Laboratories

K number K760918

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GFO 1976-08-03

ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT

Applicant Dade, Baxter Travenol Diagnostics, Inc.

K number K760318

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