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FDA 510(k)

K-ASSAY HS-CRP CONTROLS

K-Number: K011079 · 2001-05-16

ApplicantKamiya Biomedical Co.
Decision Date2001-05-16
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

K-ASSAY HS-CRP CONTROLS 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 2001-05-16 under 510(k) number K011079. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-ASSAY HS-CRP CONTROLS?

K-ASSAY HS-CRP CONTROLS is a medical device that received FDA 510(k) clearance on 2001-05-16. The listed applicant is Kamiya Biomedical Co.. The 510(k) number is K011079.

When did K-ASSAY HS-CRP CONTROLS receive FDA 510(k) clearance?

K-ASSAY HS-CRP CONTROLS received FDA 510(k) clearance on 2001-05-16, under 510(k) number K011079.

Who is the listed applicant for K-ASSAY HS-CRP CONTROLS?

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 HS-CRP CONTROLS?

The FDA product code for K-ASSAY HS-CRP CONTROLS is DCK.

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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: DCK)

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.

K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLCK201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise DiagnosticsK192028Yumizen C1200 CRPHORIBA ABX SASK192118CRP VarioSENTINEL CH. SpAK191993Yumizen C1200 CRPHORIBA ABX SASK160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics

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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