VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,— 510(k) K070819

Name: FDA 510(k) clearance K070819
Creator: U.S. Food and Drug Administration
Published: 2007-06-25

Substantially Equivalent

Bio-Rad Laboratories Inc., Clinical Systems Divisi

FDA 510(k) clearance K070819 for VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,, Substantially Equivalent on 2007-06-25. Applicant: Bio-Rad Laboratories Inc., Clinical Systems Divisi. Device class: 2.

Clearance details

Applicant: Bio-Rad Laboratories Inc., Clinical Systems Divisi
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2007-03-26
Decision date: 2007-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

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