Product Code: GIS FDA class 2 21 CFR 864.7340

Test, Fibrinogen

Hematology

Test, Fibrinogen (product code GIS) is a hematology assay used to measure the concentration of fibrinogen in plasma, a critical coagulation protein whose levels are assessed in the diagnosis of bleeding disorders, DIC, liver disease, and cardiovascular risk stratification. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7340 in the Hematology specialty (HE), it is eligible for third-party review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code GIS in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: GIS
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

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 13 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K143470	Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set	Jan 31, 2016	Substantially Equivalent	Diazyme Laboratories
K042919	FIBROTEK FIB	Nov 29, 2004	Substantially Equivalent	R2 Diagnostics, Inc.
K993482	K-ASSAY FIBRINOGEN	Dec 06, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K963902	QUANTITATIVE FIBRINOGEN ASSAY	Nov 29, 1996	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K941001	ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT	Aug 30, 1994	Substantially Equivalent	Diagnostic Specialties
K925494	BIOMERIEUX HEMOLAB FIBRINOMAT	May 18, 1993	Substantially Equivalent	Biomerieux Vitek, Inc.
K923921	IL TEST PT FIBRINOGEN HS	Oct 26, 1992	Substantially Equivalent	Instrumentation Laboratory CO
K913061	FIBRINOGEN DETERMINATION KIT	Oct 09, 1991	Substantially Equivalent	Sigma Diagnostics, Inc.
K910636	ABS CADKIT	Apr 29, 1991	Substantially Equivalent	Panbio, Inc.
K903874	FIBRINOTEST(TM) - FIBRINOGEN ASSAY	Feb 14, 1991	Substantially Equivalent	Haemachem, Inc.
K881685	FIBRINOGENTEST-O	Aug 09, 1988	Substantially Equivalent	Diatech, Inc.
K881150	KINETIC FIBRINOGEN ASSAY	Mar 28, 1988	Substantially Equivalent	Bio/Data Corp.
K781880	ASSAY KIT, THROMBO-SCREEN	Dec 04, 1978	Substantially Equivalent	Pacific Hemostasis