Cleared Traditional

ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT

K123953 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry
May 2013
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K123953 is an FDA 510(k) clearance for the ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on May 2, 2013, 132 days after receiving the submission on December 21, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K123953 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2012
Decision Date May 02, 2013
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHS — Enzymatic, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160

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