Cleared Traditional

ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT

K122757 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry
Oct 2012
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K122757 is an FDA 510(k) clearance for the ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on October 5, 2012, 28 days after receiving the submission on September 7, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K122757 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2012
Decision Date October 05, 2012
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

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