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FDA 510(k)

K-ASSAY FIBRINOGEN

K-Number: K993482 · 1999-12-06

ApplicantKamiya Biomedical Co.
Decision Date1999-12-06
Product CodeGIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

K-ASSAY FIBRINOGEN is the device name listed in this FDA 510(k) record. The listed applicant is Kamiya Biomedical Co.. It received FDA 510(k) clearance on 1999-12-06 under 510(k) number K993482. 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 K-ASSAY FIBRINOGEN?

K-ASSAY FIBRINOGEN is a medical device that received FDA 510(k) clearance on 1999-12-06. The listed applicant is Kamiya Biomedical Co.. The 510(k) number is K993482.

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

K-ASSAY FIBRINOGEN received FDA 510(k) clearance on 1999-12-06, under 510(k) number K993482.

Who is the listed applicant for K-ASSAY FIBRINOGEN?

The FDA 510(k) record lists Kamiya Biomedical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-ASSAY FIBRINOGEN?

The FDA product code for K-ASSAY FIBRINOGEN is GIS.

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Other records listing Kamiya Biomedical Co. 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.

K093137K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROLK091486K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATORK050944K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SETK042241K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093CK030687K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091CK023828K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR

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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.K963902QUANTITATIVE FIBRINOGEN ASSAYOrtho Diagnostic Systems, Inc.K941001ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KITDiagnostic SpecialtiesK925494BIOMERIEUX HEMOLAB FIBRINOMATBiomerieux Vitek, Inc.K923921IL TEST PT FIBRINOGEN HSInstrumentation Laboratory CO

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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