Variant(Tm) II Turbo HBA1C Kit - 2.0

Q: What is the product code of K130990?

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

FDA 510(k) K130990 · Bio-Rad Laboratories, Inc., Clinical Systems Divis

Substantially Equivalent

510(k) numberK130990

Submission

Device name: Variant(Tm) II Turbo HBA1C Kit - 2.0
Applicant: Bio-Rad Laboratories, Inc., Clinical Systems Divis
Hercules, CA, US
Received: April 10, 2013
Decision date: May 9, 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

510(k)	Device	Decision
K130860	Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM…LCP · Special	04/25/2013SE
K122472	Variant II Turbo HBA1C KIT-2.0 Variant II Turbo Hemoglobin Testing SystemLCP · Traditional	10/26/2012SE

Questions and answers

When was Variant(Tm) II Turbo HBA1C Kit - 2.0 cleared by the FDA?

Variant(Tm) II Turbo HBA1C Kit - 2.0 (K130990) received a 510(k) decision of Substantially Equivalent on May 9, 2013, 29 days after the submission was received.

What is the product code of K130990?

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