Cleared Traditional

ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT

K113253 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry
May 2012
Decision
197d
Days
Class 1
Risk

About This 510(k) Submission

K113253 is an FDA 510(k) clearance for the ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on May 17, 2012, 197 days after receiving the submission on November 2, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number K113253 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2011
Decision Date May 17, 2012
Days to Decision 197 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2160

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