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FDA 510(k)

K-ASSAY MULTI-ANALYTE CALIBRATOR

K-Number: K993853 · 1999-12-27

ApplicantKamiya Biomedical Co.
Decision Date1999-12-27
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

K-ASSAY MULTI-ANALYTE 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 1999-12-27 under 510(k) number K993853. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-ASSAY MULTI-ANALYTE CALIBRATOR?

K-ASSAY MULTI-ANALYTE CALIBRATOR is a medical device that received FDA 510(k) clearance on 1999-12-27. The listed applicant is Kamiya Biomedical Co.. The 510(k) number is K993853.

When did K-ASSAY MULTI-ANALYTE CALIBRATOR receive FDA 510(k) clearance?

K-ASSAY MULTI-ANALYTE CALIBRATOR received FDA 510(k) clearance on 1999-12-27, under 510(k) number K993853.

Who is the listed applicant for K-ASSAY MULTI-ANALYTE 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 MULTI-ANALYTE CALIBRATOR?

The FDA product code for K-ASSAY MULTI-ANALYTE CALIBRATOR is JIX.

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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: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare 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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