DETER. OF HEMOGLOBIN A2 USING THE DIAMAT— 510(k) K875102

Name: FDA 510(k) clearance K875102
Creator: U.S. Food and Drug Administration
Published: 1988-02-24

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K875102 for DETER. OF HEMOGLOBIN A2 USING THE DIAMAT, Substantially Equivalent on 1988-02-24. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code JPD
Device class: Class 2
Regulation: 21 CFR 864.7400
Advisory panel: Hematology
Date received: 1987-12-10
Decision date: 1988-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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