Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM Software, CDM Software

FDA 510(k) K130860 · Bio-Rad Laboratories, Inc., Clinical Systems Divis

Substantially Equivalent

510(k) numberK130860

Submission

Device name
Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM Software, CDM Software
Applicant
Bio-Rad Laboratories, Inc., Clinical Systems Divis
Hercules, CA, US
Received
March 28, 2013
Decision date
April 25, 2013
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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More from Alfa Wassermann Diagnostic Technologies, LLC

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Questions and answers

When was Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM Software, CDM Software cleared by the FDA?

Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM Software, CDM Software (K130860) received a 510(k) decision of Substantially Equivalent on April 25, 2013, 28 days after the submission was received.

What is the product code of K130860?

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