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FDA 510(k)

K-ASSAY APO B

K-Number: K993354 · 1999-10-28

ApplicantKamiya Biomedical Co.
Decision Date1999-10-28
Product CodeDER
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

K-ASSAY APO B 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 1999-10-28 under 510(k) number K993354. The device is classified under product code DER. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-ASSAY APO B?

K-ASSAY APO B is a medical device that received FDA 510(k) clearance on 1999-10-28. The listed applicant is Kamiya Biomedical Co.. The 510(k) number is K993354.

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

K-ASSAY APO B received FDA 510(k) clearance on 1999-10-28, under 510(k) number K993354.

Who is the listed applicant for K-ASSAY APO B?

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 APO B?

The FDA product code for K-ASSAY APO B is DER.

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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: DER)

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.

K013249TINA-QUANT APOLIPOPROTEIN VER.2Roche Diagnostics Corp.K000921BAYER ADVIA IMS SYSTEM; 200 + 3Bayer Corp.K993345K-ASSAY APO AIKamiya Biomedical Co.K990594INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1Roche Diagnostics Corp.K983289APOLIPOPROTEIN A1Abbott LaboratoriesK964292N-ASSAY TIA APO A1 TEST KITCrestat Diagnostics, 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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