Cleared Traditional

ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT

K113389 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry
Aug 2012
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K113389 is an FDA 510(k) clearance for the ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT, a Urease, Photometric, Urea Nitrogen (Class II — Special Controls, product code CDN), submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on August 10, 2012, 268 days after receiving the submission on November 16, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K113389 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2011
Decision Date August 10, 2012
Days to Decision 268 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDN — Urease, Photometric, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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