VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM— 510(k) K122472

Name: FDA 510(k) clearance K122472
Creator: U.S. Food and Drug Administration
Published: 2012-10-26

Substantially Equivalent

Bio-Rad Laboratories, Inc., Clinical Systems Divis

FDA 510(k) clearance K122472 for VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM, Substantially Equivalent on 2012-10-26. Applicant: Bio-Rad Laboratories, Inc., Clinical Systems Divis. Device class: 2.

Clearance details

Applicant: Bio-Rad Laboratories, Inc., Clinical Systems Divis
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2012-08-14
Decision date: 2012-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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