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FDA 510(k)

MYOGLOBIN ELISA TEST KIT

K-Number: K923195 · 1992-11-06

ApplicantImmuno Diagnostic Center, Inc.
Decision Date1992-11-06
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MYOGLOBIN ELISA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Diagnostic Center, Inc.. It received FDA 510(k) clearance on 1992-11-06 under 510(k) number K923195. 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 MYOGLOBIN ELISA TEST KIT?

MYOGLOBIN ELISA TEST KIT is a medical device that received FDA 510(k) clearance on 1992-11-06. The listed applicant is Immuno Diagnostic Center, Inc.. The 510(k) number is K923195.

When did MYOGLOBIN ELISA TEST KIT receive FDA 510(k) clearance?

MYOGLOBIN ELISA TEST KIT received FDA 510(k) clearance on 1992-11-06, under 510(k) number K923195.

Who is the listed applicant for MYOGLOBIN ELISA TEST KIT?

The FDA 510(k) record lists Immuno Diagnostic Center, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYOGLOBIN ELISA TEST KIT?

The FDA product code for MYOGLOBIN ELISA TEST KIT is DDR.

Related Clinical Trials

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Other records listing Immuno Diagnostic Center, Inc. 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.

K912543MICRO ALBUMIN EIA TEST KITK904038MYOGLOBIN RIA TEST KIT

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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