VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM— 510(k) K140801

Name: FDA 510(k) clearance K140801
Creator: U.S. Food and Drug Administration
Published: 2014-06-25

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K140801 for VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM, Substantially Equivalent on 2014-06-25. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2014-03-31
Decision date: 2014-06-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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