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FDA 510(k)

KINETIC FIBRINOGEN ASSAY

K-Number: K881150 · 1988-03-28

ApplicantBio/Data Corp.
Decision Date1988-03-28
Product CodeGIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

KINETIC FIBRINOGEN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bio/Data Corp.. It received FDA 510(k) clearance on 1988-03-28 under 510(k) number K881150. 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 KINETIC FIBRINOGEN ASSAY?

KINETIC FIBRINOGEN ASSAY is a medical device that received FDA 510(k) clearance on 1988-03-28. The listed applicant is Bio/Data Corp.. The 510(k) number is K881150.

When did KINETIC FIBRINOGEN ASSAY receive FDA 510(k) clearance?

KINETIC FIBRINOGEN ASSAY received FDA 510(k) clearance on 1988-03-28, under 510(k) number K881150.

Who is the listed applicant for KINETIC FIBRINOGEN ASSAY?

The FDA 510(k) record lists Bio/Data Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KINETIC FIBRINOGEN ASSAY?

The FDA product code for KINETIC FIBRINOGEN ASSAY is GIS.

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Other records listing Bio/Data Corp. 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.

K001891MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-CK943153MICROSAMPLE COAGULATION ANALYZERK893650PLATELET AGGREGATION PROFILER MODEL PAP-4CK873382PLATELET EXTRACT REAGENTK860751VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMAK860342MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP

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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.

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