Cleared Traditional

ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT

K131975 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry
Oct 2013
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K131975 is an FDA 510(k) clearance for the ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT, a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II — Special Controls, product code CFJ), submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on October 2, 2013, 96 days after receiving the submission on June 28, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K131975 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2013
Decision Date October 02, 2013
Days to Decision 96 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CFJ — Nad Reduction/nadh Oxidation, Lactate Dehydrogenase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1440

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