Product Code: KQJ FDA class 2 21 CFR 864.7340

System, Fibrinogen Determination

Hematology

This device is a fibrinogen determination system, an in vitro diagnostic system used to measure plasma fibrinogen levels, an important coagulation factor, to assess bleeding risk and monitor conditions such as disseminated intravascular coagulation (DIC) and liver disease. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KQJ, regulated under 21 CFR 864.7340 within the Hematology specialty. This device is eligible for third-party review.

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FEI Numbers

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Basic Information

Product Code: KQJ
Device Class: FDA class 2
Regulation Number: 864.7340
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
K251968	HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL	Jul 24, 2025	Substantially Equivalent	Instrumentation Laboratory (IL) Co.
K073367	HEMOSIL FIBRINOGEN-C	Dec 27, 2007	Substantially Equivalent	Instrumentation Laboratory CO
K050928	DADE THROMBIN REAGENT	Jun 29, 2005	Substantially Equivalent	Dade Behring, Inc.
K971858	SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)	Oct 09, 1997	Substantially Equivalent	Sigma Diagnostics, Inc.
K970189	FIF TM	May 21, 1997	Substantially Equivalent	Panbio, Inc.
K965113	N-ASSAY TIA FIBRINOGEN TEST KIT	Apr 16, 1997	Substantially Equivalent	Crestat Diagnostics, Inc.
K934326	MULTIFIBREN U	Apr 19, 1994	Substantially Equivalent	Behring Diagnostics, Inc.
K931721	IL TEST FIBRINOGEN-C	Aug 13, 1993	Substantially Equivalent	Instrumentation Laboratory CO
K922416	FIBRINOGEN RID TEST KIT	Mar 09, 1993	Substantially Equivalent	The Binding Site, Ltd.
K925988	MULTIFIBREN	Mar 01, 1993	Substantially Equivalent	Behring Diagnostics, Inc.
K923593	HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS	Sep 22, 1992	Substantially Equivalent	International Technidyne Corp.
K920258	QBC FIBRINOGEN	Jun 26, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K900939	SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)	May 16, 1990	Substantially Equivalent	Incstar Corp.
K900895	COAG-A-MATE - RA4	Apr 16, 1990	Substantially Equivalent	Organon Teknika Corp.
K896052	FIBRINOGEN ASSAY KIT	Nov 09, 1989	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K884179	TURBOX FIBRINOGEN	Dec 20, 1988	Substantially Equivalent	Unipath , Ltd.
K841366	DIA FIBRIN	Jun 01, 1984	Substantially Equivalent	Diatech, Inc.
K841020	FIBRINOGEN ASSAY KIT	May 02, 1984	Substantially Equivalent	Helena Laboratories
K840211	FIBRI-PREST AUTOMATE HA34	Mar 02, 1984	Substantially Equivalent	Wellcome Diagnostics
K834571	FIBRINOGEN TEST	Feb 04, 1984	Substantially Equivalent	Diatech, Inc.
K812629	ACA FIBRINOGEN TEST PACK	Oct 08, 1981	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K812570	LABCER FIBRINOGEN ASSAY KIT & CALIBR.	Oct 02, 1981	Substantially Equivalent	Sherwood Medical Co.
K812108	LOW FIBRINOGEN CONTROL	Sep 24, 1981	Substantially Equivalent	Bio/Data Corp.
K811069	FIBRINOGEN CONTROL PLASMA	Jul 10, 1981	Substantially Equivalent	American Dade
K810058	ORTHO QUANTITATIVE FIBRINOGEN ASSAY	Feb 26, 1981	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K801926	SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA	Sep 09, 1980	Substantially Equivalent	Sigma Chemical Co.
K800826	FIBRINOGEN SCREEN	May 30, 1980	Substantially Equivalent	Pacific Hemostasis
K792563	THROMBOKINETIC FIBRINOGEN ASSAY	Jan 11, 1980	Substantially Equivalent	Bio/Data Corp.