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FDA 510(k)

K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR

K-Number: K992976 · 1999-11-01

ApplicantKamiya Biomedical Co.
Decision Date1999-11-01
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN 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 1999-11-01 under 510(k) number K992976. The device is classified under product code DDR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR?

K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 1999-11-01. The listed applicant is Kamiya Biomedical Co.. The 510(k) number is K992976.

When did K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR receive FDA 510(k) clearance?

K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR received FDA 510(k) clearance on 1999-11-01, under 510(k) number K992976.

Who is the listed applicant for K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN 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 MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR?

The FDA product code for K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR is DDR.

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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: DDR)

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.

K231832Access MyoglobinBeckman Coulter, Inc.K123785DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SETDiazyme LaboratoriesK122599ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATORSiemens Healthcare Diagnostics, Inc.K083260ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBINRoche DiagnosticsK080481ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORSBeckman Coulter, Inc.K061683TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEMRoche Diagnostics Corp.

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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