Product Code: GGW FDA class 2 21 CFR 864.7925

Test, Time, Partial Thromboplastin

Hematology

The Test, Time, Partial Thromboplastin (product code GGW) is a hematology reagent system used to perform the partial thromboplastin time (PTT) test, which evaluates the intrinsic coagulation pathway and is used to monitor heparin anticoagulation therapy and screen for clotting factor deficiencies. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7925 in the Hematology specialty (HE), it is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: GGW
Device Class: FDA class 2
Regulation Number: 864.7925
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 32 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260551	HemosIL Factor V Leiden (APC Resistance V)	Mar 20, 2026	Substantially Equivalent	Instrumentation Laboratory (IL) Co.
K090105	LUPOTEK KCT	Dec 30, 2010	Substantially Equivalent	R2 Diagnostics, Inc.
K083729	HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN	May 08, 2009	Substantially Equivalent	Aniara Diagnostica, LLC
K060284	CRYOCHECK CLOT APCR	May 10, 2006	Substantially Equivalent	Precision Biologic, Inc.
K042762	PEFAKIT APC-R FACTOR V LEIDEN	Dec 22, 2004	Substantially Equivalent	Pentapharm , Ltd.
K033471	PHOSPHOLIN ES AND CALCIUM CHLORIDE	Feb 04, 2004	Substantially Equivalent	R2 Diagnostics, Inc.
K992456	GRADILEIDEN V TEST	Dec 21, 1999	Substantially Equivalent	Gradipore , Ltd.
K982062	CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10	Jan 13, 1999	Substantially Equivalent	Precision Biologicals, Inc.
K963111	COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S	Dec 23, 1996	Substantially Equivalent	Chromogenix AB
K945940	COATEST(R) APC(TM) RESISTANCE	Aug 07, 1995	Substantially Equivalent	Axis-Shield Doc AS
K941210	PTT-LT TEST KIT	Mar 21, 1995	Unknown	American Bioproducts Co.
K924370	STACLOT(R) PNP TEST KIT	Aug 09, 1993	Substantially Equivalent	American Bioproducts Co.
K921684	PTT-LA TEST KIT	Jun 09, 1992	Substantially Equivalent	American Bioproducts Co.
K915463	ACTIVATED PARTIAL THROMBOPLASTIN TIME	Jan 23, 1992	Substantially Equivalent	Sigma Diagnostics, Inc.
K902236	READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT	Aug 14, 1990	Substantially Equivalent	Biosearch Medical Products, Inc.
K873382	PLATELET EXTRACT REAGENT	Nov 20, 1987	Substantially Equivalent	Bio/Data Corp.
K863594	ACTIN FSL ACTIVATED PTT REAGENT	Oct 17, 1986	Substantially Equivalent	American Dade
K861190	PTT AUTOMATE TEST KIT	Jun 23, 1986	Substantially Equivalent	American Bioproducts Co.
K853897	CITREX H	Oct 10, 1985	Substantially Equivalent	Bio/Data Corp.
K852195	CEPHALINEX ACTIVATED PTT REAGENT	Aug 12, 1985	Substantially Equivalent	Bio/Data Corp.
K851126	ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC	May 29, 1985	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K841522	CALCIUM CHLORIDE	Apr 30, 1984	Substantially Equivalent	Diatech, Inc.
K830320	ACTIVAT-PARTIAL THROMBO-PLASTIN	Apr 05, 1983	Substantially Equivalent	Helena Laboratories
K822782	ACUSCREEN	Oct 08, 1982	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K811589	ACTIN FS ACTIVATED PTT REAGENT	Jul 16, 1981	Substantially Equivalent	American Dade
K802232	AB-TROL COAGULATION CONTROL	Nov 12, 1980	Substantially Equivalent	Helena Laboratories
K801932	HEP-TROL	Sep 09, 1980	Substantially Equivalent	Helena Laboratories
K801460	PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT	Jul 28, 1980	Substantially Equivalent	Pacific Hemostasis
K800925	VERIFY S PROD. #34141	Jul 21, 1980	Substantially Equivalent	General Diagnostics
K800787	ANTIBODY TO VARICELLA-ZOSTER VIRUS	Jul 14, 1980	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K800725	A-GENT QUANTICHROM THROMBIGEN I	Jun 04, 1980	Substantially Equivalent	Abbott Laboratories
K792048	LANCER COAGENT APTT KIT	Nov 05, 1979	Substantially Equivalent	Sherwood Medical Co.