LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL— 510(k) K911347

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K911347 for LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL, Substantially Equivalent on 1991-06-10. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code JCM
Device class: Class 2
Regulation: 21 CFR 864.7415
Advisory panel: Hematology
Date received: 1991-03-27
Decision date: 1991-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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