MODIFIED HEMOGLOBIN REAGENT SET— 510(k) K894951

Name: FDA 510(k) clearance K894951
Creator: U.S. Food and Drug Administration
Published: 1989-10-24

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.. Device class: 2.

Clearance details

Applicant: Macomb Biotechnology, Inc.
Product code: Code GKK
Device class: Class 2
Regulation: 21 CFR 864.7500
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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