VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0— 510(k) K063400

Name: FDA 510(k) clearance K063400
Creator: U.S. Food and Drug Administration
Published: 2006-12-01

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K063400 for VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0, Substantially Equivalent on 2006-12-01. 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: 2006-11-09
Decision date: 2006-12-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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