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FDA 510(k)

MODIFIED HEMOGLOBIN REAGENT SET

K-Number: K894951 · 1989-10-24

ApplicantMacomb Biotechnology, Inc.
Decision Date1989-10-24
Product CodeGKK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MODIFIED HEMOGLOBIN REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Macomb Biotechnology, Inc.. It received FDA 510(k) clearance on 1989-10-24 under 510(k) number K894951. The device is classified under product code GKK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED HEMOGLOBIN REAGENT SET?

MODIFIED HEMOGLOBIN REAGENT SET is a medical device that received FDA 510(k) clearance on 1989-10-24. The listed applicant is Macomb Biotechnology, Inc.. The 510(k) number is K894951.

When did MODIFIED HEMOGLOBIN REAGENT SET receive FDA 510(k) clearance?

MODIFIED HEMOGLOBIN REAGENT SET received FDA 510(k) clearance on 1989-10-24, under 510(k) number K894951.

Who is the listed applicant for MODIFIED HEMOGLOBIN REAGENT SET?

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

What is the FDA product code for MODIFIED HEMOGLOBIN REAGENT SET?

The FDA product code for MODIFIED HEMOGLOBIN REAGENT SET is GKK.

Related Clinical Trials

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.

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Other records listing Macomb Biotechnology, 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.

K871902THE URIC ACID REAGENT SET

Related Devices (Code: GKK)

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.

K896922RAICHEM TM HEMOGLOBIN REAGENTReagents Applications, Inc.K883992KVM PREPACK HEMATOLOGY REAGENT SETKvm Technologies, Inc.K821202HEMOGLOBIN REAGENT SETOmega Medical ElectronicsK771716CYMET-PLUSJ.T. Baker Chemical Co.K771090UNIPAK HEMOGLOBINHarlecoK770803HEMOTOLOGY PRODU&TS (5 IN ALL)Hycel, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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