Cleared Traditional

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

K123322 · Alfa Wassermann Diagnostics Technologies, LLC · Chemistry
May 2013
Decision
207d
Days
Class 2
Risk

About This 510(k) Submission

K123322 is an FDA 510(k) clearance for the ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT, a Urease, Photometric, Urea Nitrogen (Class II — Special Controls, product code CDN), submitted by Alfa Wassermann Diagnostics Technologies, LLC (West Caldwell, US). The FDA issued a Cleared decision on May 21, 2013, 207 days after receiving the submission on October 26, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K123322 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2012
Decision Date May 21, 2013
Days to Decision 207 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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