Cleared Special

K130860 - VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE (FDA 510(k) Clearance)

K130860 · Bio-Rad Laboratories, Inc., Clinical Systems Divis · Chemistry device

Apr 2013

Decision

28d

Days

Class 2

Risk

K130860 is an FDA 510(k) clearance for the VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).

Submitted by Bio-Rad Laboratories, Inc., Clinical Systems Divis (Hercules, US). The FDA issued a Cleared decision on April 25, 2013, 28 days after receiving the submission on March 28, 2013.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number	K130860 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 28, 2013
Decision Date	April 25, 2013
Days to Decision	28 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Summary PDF