Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total GHB Program

FDA 510(k) K063643 · Bio-Rad Laboratories Inc., Clinical Systems Divisi

Substantially Equivalent

510(k) numberK063643

Submission

Device name
Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total GHB Program
Applicant
Bio-Rad Laboratories Inc., Clinical Systems Divisi
Hercules, CA, US
Received
December 7, 2006
Decision date
December 27, 2006
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LCP – Assay, Glycosylated Hemoglobin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7470
Specialty
Hematology

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Questions and answers

When was Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total GHB Program cleared by the FDA?

Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total GHB Program (K063643) received a 510(k) decision of Substantially Equivalent on December 27, 2006, 20 days after the submission was received.

What is the product code of K063643?

The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.