VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE— 510(k) K130860

Name: FDA 510(k) clearance K130860
Creator: U.S. Food and Drug Administration
Published: 2013-04-25

Substantially Equivalent

Bio-Rad Laboratories, Inc., Clinical Systems Divis

FDA 510(k) clearance K130860 for VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE, Substantially Equivalent on 2013-04-25. 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: 2013-03-28
Decision date: 2013-04-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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