Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FIBRINOTEST(TM) - FIBRINOGEN ASSAY

K-Number: K903874 · 1991-02-14

ApplicantHaemachem, Inc.
Decision Date1991-02-14
Product CodeGIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FIBRINOTEST(TM) - FIBRINOGEN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Haemachem, Inc.. It received FDA 510(k) clearance on 1991-02-14 under 510(k) number K903874. The device is classified under product code GIS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRINOTEST(TM) - FIBRINOGEN ASSAY?

FIBRINOTEST(TM) - FIBRINOGEN ASSAY is a medical device that received FDA 510(k) clearance on 1991-02-14. The listed applicant is Haemachem, Inc.. The 510(k) number is K903874.

When did FIBRINOTEST(TM) - FIBRINOGEN ASSAY receive FDA 510(k) clearance?

FIBRINOTEST(TM) - FIBRINOGEN ASSAY received FDA 510(k) clearance on 1991-02-14, under 510(k) number K903874.

Who is the listed applicant for FIBRINOTEST(TM) - FIBRINOGEN ASSAY?

The FDA 510(k) record lists Haemachem, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIBRINOTEST(TM) - FIBRINOGEN ASSAY?

The FDA product code for FIBRINOTEST(TM) - FIBRINOGEN ASSAY is GIS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Haemachem, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K853239HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAYK841957BOVINE FACTOR XA-HUMAN FACTOR XAK841956BOVINE THROMBIN, HUMAN THROMBIN

Related Devices (Code: GIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K143470Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control SetDiazyme LaboratoriesK042919FIBROTEK FIBR2 Diagnostics, Inc.K993482K-ASSAY FIBRINOGENKamiya Biomedical Co.K963902QUANTITATIVE FIBRINOGEN ASSAYOrtho Diagnostic Systems, Inc.K941001ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KITDiagnostic SpecialtiesK925494BIOMERIEUX HEMOLAB FIBRINOMATBiomerieux Vitek, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑