Cleared Traditional

ACE ALT REAGENT

K113382 · Alfa Wassermann · Chemistry
Jul 2012
Decision
246d
Days
Class 1
Risk

About This 510(k) Submission

K113382 is an FDA 510(k) clearance for the ACE ALT REAGENT, a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I — General Controls, product code CKA), submitted by Alfa Wassermann (West Caldwell, US). The FDA issued a Cleared decision on July 19, 2012, 246 days after receiving the submission on November 16, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K113382 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2011
Decision Date July 19, 2012
Days to Decision 246 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CKA — Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1030

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