Cleared Traditional

ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72

K063306 · Alfa Wassermann, Inc. · Chemistry

Apr 2007

Decision

167d

Days

Class 2

Risk

About This 510(k) Submission

K063306 is an FDA 510(k) clearance for the ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Alfa Wassermann, Inc. (West Caldwell, US). The FDA issued a Cleared decision on April 17, 2007, 167 days after receiving the submission on November 1, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number	K063306 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 2006
Decision Date	April 17, 2007
Days to Decision	167 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF