Cleared Traditional

ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT

K113374 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry
Jul 2012
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K113374 is an FDA 510(k) clearance for the ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on July 13, 2012, 240 days after receiving the submission on November 16, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K113374 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2011
Decision Date July 13, 2012
Days to Decision 240 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIX — Bromcresol Green Dye-binding, Albumin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1035

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