Cleared Traditional

ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT

K113438 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry
Jun 2012
Decision
193d
Days
Class 1
Risk

About This 510(k) Submission

K113438 is an FDA 510(k) clearance for the ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT, a Ferrozine (colorimetric) Iron Binding Capacity (Class I — General Controls, product code JMO), submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on June 1, 2012, 193 days after receiving the submission on November 21, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number K113438 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2011
Decision Date June 01, 2012
Days to Decision 193 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JMO — Ferrozine (colorimetric) Iron Binding Capacity
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1415

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