MODIFIED HEMOGLOBIN REAGENT SET— 510(k) K894951

Substantially Equivalent

Macomb Biotechnology, Inc.

FDA 510(k) clearance K894951 for MODIFIED HEMOGLOBIN REAGENT SET, Substantially Equivalent on 1989-10-24. Applicant: Macomb Biotechnology, Inc..

Clearance details

Applicant: Macomb Biotechnology, Inc.
Product code: Code GKK
Advisory panel: Hematology
Date received: 1989-07-20
Decision date: 1989-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Romeo, MI, US

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