Product Code: GHH FDA class 2 21 CFR 864.7320

Fibrin Split Products

Hematology

Fibrin Split Products (product code GHH) are hematology assay reagents used to detect fibrin degradation products (FDPs) in plasma or serum, which are markers of fibrinolytic activity and are elevated in conditions such as disseminated intravascular coagulation (DIC) and thromboembolic disorders. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7320 in the Hematology specialty (HE), it is eligible for third-party review.

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510(k)s

FEI Numbers

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Basic Information

Product Code: GHH
Device Class: FDA class 2
Regulation Number: 864.7320
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 28 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K112120	DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET	Jan 24, 2013	Substantially Equivalent	Diazyme Laboratories
K072288	PATHFAST D-DIMER	May 06, 2009	Substantially Equivalent	Mitsubishi Kagaku Iatron
K070453	OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL	Jun 11, 2007	Substantially Equivalent	Olympus Life & Material Science Europa GmbH (Irish
K062203	TINA-QUANT D-DIMER TEST SYSTEM	Mar 14, 2007	Substantially Equivalent	Roche Diagnostics Corp.
K042890	TRIAGE D-DIMER TEST, MODEL 98100	Nov 29, 2004	Substantially Equivalent	Biosite Incorporated
K030740	MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM	Apr 01, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K021877	MDA D-DIMER	Aug 07, 2002	Substantially Equivalent	bioMerieux, Inc.
K011143	TINA-QUANT D-DIMER TEST SYSTEM	May 29, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K993276	SIMPLIFY D-DIMER, MODEL DCGK1	Dec 14, 1999	Substantially Equivalent	Agen Biomedical , Ltd.
K972316	OPUS D-DIMER	Sep 09, 1997	Substantially Equivalent	Behring Diagnostics, Inc.
K945642	AGEN DIMERTEST GOLD EIA	Oct 25, 1995	Substantially Equivalent	Agen Biomedical , Ltd.
K921989	FDP - SLIDEX DIRECT	Nov 03, 1993	Substantially Equivalent	Biomerieux Vitek, Inc.
K920668	MINUTEX D-DIMER LATEX TEST	Oct 16, 1992	Substantially Equivalent	Biopool AB
K905643	BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY	Apr 12, 1991	Substantially Equivalent	Agen Biomedical , Ltd.
K893961	ABBOTT IMX(TM) D-DIMER	Aug 03, 1989	Substantially Equivalent	Abbott Laboratories
K890422	ABBOTT TESTPACK(TM) D-DIMER	Mar 27, 1989	Substantially Equivalent	Abbott Laboratories
K890399	MODIFIED D-DI-TEST KIT	Feb 07, 1989	Substantially Equivalent	American Bioproducts Co.
K880077	FIBRINOSTICON	Feb 09, 1988	Substantially Equivalent	Organon Teknika Corp.
K872360	DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET	Jul 06, 1987	Substantially Equivalent	American Dade
K861973	D-DI TEST KIT	Sep 04, 1986	Substantially Equivalent	American Bioproducts Co.
K852848	FDP ASSAY-20 TEST KIT	Oct 10, 1985	Substantially Equivalent	American Bioproducts Co.
K852520	ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK	Oct 04, 1985	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K852512	THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT	Sep 17, 1985	Substantially Equivalent	Pacific Hemostasis
K852176	DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR	Aug 12, 1985	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K842277	DIMERTEST LATEX	Apr 03, 1985	Substantially Equivalent	Mabco, Inc.
K812298	FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN	Dec 17, 1981	Substantially Equivalent	Syn-Kit, Inc.
K801841	FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP)	Oct 10, 1980	Substantially Equivalent	American Hospital Supply Corp.
K791358	FIBRO-TEC TEST KIT	Sep 04, 1979	Substantially Equivalent	Calbiochem-Behring Corp.