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FDA 510(k)

K-ASSAY C3

K-Number: K993437 · 1999-11-24

ApplicantKamiya Biomedical Co.
Decision Date1999-11-24
Product CodeCZW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

K-ASSAY C3 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 1999-11-24 under 510(k) number K993437. The device is classified under product code CZW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-ASSAY C3?

K-ASSAY C3 is a medical device that received FDA 510(k) clearance on 1999-11-24. The listed applicant is Kamiya Biomedical Co.. The 510(k) number is K993437.

When did K-ASSAY C3 receive FDA 510(k) clearance?

K-ASSAY C3 received FDA 510(k) clearance on 1999-11-24, under 510(k) number K993437.

Who is the listed applicant for K-ASSAY C3?

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 C3?

The FDA product code for K-ASSAY C3 is CZW.

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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: CZW)

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.

K100179SPAPLUSThe Binding Site Group , Ltd.K063150COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROLThermo Electron OYK061852DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGHDade Behring, Inc.K050665N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)Dade Behring, Inc.K042494VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND IIIOrtho-Clinical DiagnosticsK032796IBL C3D-CIC EIA TESTIbl GmbH

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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