Cleared Traditional

K113262 - ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT
(FDA 510(k) Clearance)

K113262 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry

Jul 2012

Decision

242d

Days

Class 1

Risk

K113262 is an FDA 510(k) clearance for the ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES 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 July 3, 2012, 242 days after receiving the submission on November 4, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number	K113262 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 04, 2011
Decision Date	July 03, 2012
Days to Decision	242 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF