RADIAS MONOCLONAL HBA 1C ASSAY— 510(k) K935613

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K935613 for RADIAS MONOCLONAL HBA 1C ASSAY, Substantially Equivalent on 1994-04-05. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1993-11-22
Decision date: 1994-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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