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FDA 510(k)

K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR

K-Number: K091486 · 2010-04-29

ApplicantKamiya Biomedical Co.
Decision Date2010-04-29
Product CodeDCF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR 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 2010-04-29 under 510(k) number K091486. The device is classified under product code DCF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR?

K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 2010-04-29. The listed applicant is Kamiya Biomedical Co.. The 510(k) number is K091486.

When did K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR receive FDA 510(k) clearance?

K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR received FDA 510(k) clearance on 2010-04-29, under 510(k) number K091486.

Who is the listed applicant for K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR?

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 MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR?

The FDA product code for K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR is DCF.

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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 CONTROLK050944K-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-CALIBRK023853K-ASSAY LP(A) CONTROLS

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Related Devices (Code: DCF)

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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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