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FDA 510(k)

FIBRINOGENTEST-O

K-Number: K881685 · 1988-08-09

ApplicantDiatech, Inc.
Decision Date1988-08-09
Product CodeGIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FIBRINOGENTEST-O is the device name listed in this FDA 510(k) record. The listed applicant is Diatech, Inc.. It received FDA 510(k) clearance on 1988-08-09 under 510(k) number K881685. 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 FIBRINOGENTEST-O?

FIBRINOGENTEST-O is a medical device that received FDA 510(k) clearance on 1988-08-09. The listed applicant is Diatech, Inc.. The 510(k) number is K881685.

When did FIBRINOGENTEST-O receive FDA 510(k) clearance?

FIBRINOGENTEST-O received FDA 510(k) clearance on 1988-08-09, under 510(k) number K881685.

Who is the listed applicant for FIBRINOGENTEST-O?

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

What is the FDA product code for FIBRINOGENTEST-O?

The FDA product code for FIBRINOGENTEST-O is GIS.

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Other records listing Diatech, 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.

K854938COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.K854089DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENTK854090DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENTK842286DIA T1, T2 & T3K841366DIA FIBRINK841462HEPARIN COAGULATION CONTROL PLASMA 1-

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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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