Cleared Traditional

ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT

K131515 · Alfa Wassermann · Chemistry
Aug 2013
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K131515 is an FDA 510(k) clearance for the ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT, a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II — Special Controls, product code KLI), submitted by Alfa Wassermann (West Caldwell, US). The FDA issued a Cleared decision on August 14, 2013, 78 days after receiving the submission on May 28, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K131515 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2013
Decision Date August 14, 2013
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

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