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FDA 510(k)

QUANTEX MYOGLOBIN

K-Number: K042982 · 2004-12-22

ApplicantInstrumentation Laboratory CO
Decision Date2004-12-22
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTEX MYOGLOBIN is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2004-12-22 under 510(k) number K042982. 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 QUANTEX MYOGLOBIN?

QUANTEX MYOGLOBIN is a medical device that received FDA 510(k) clearance on 2004-12-22. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K042982.

When did QUANTEX MYOGLOBIN receive FDA 510(k) clearance?

QUANTEX MYOGLOBIN received FDA 510(k) clearance on 2004-12-22, under 510(k) number K042982.

Who is the listed applicant for QUANTEX MYOGLOBIN?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTEX MYOGLOBIN?

The FDA product code for QUANTEX MYOGLOBIN is DDR.

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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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