Cleared Traditional

ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT

K131488 · Alfa Wassermann Diagnostics Technologies, LLC · Chemistry
Aug 2013
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K131488 is an FDA 510(k) clearance for the ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Alfa Wassermann Diagnostics Technologies, LLC (West Caldwell, US). The FDA issued a Cleared decision on August 19, 2013, 88 days after receiving the submission on May 23, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K131488 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2013
Decision Date August 19, 2013
Days to Decision 88 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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