Cleared Traditional

ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT

K113435 · Alfa Wassermann · Chemistry

Jul 2012

Decision

224d

Days

Class 2

Risk

About This 510(k) Submission

K113435 is an FDA 510(k) clearance for the ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Alfa Wassermann (West Caldwell, US). The FDA issued a Cleared decision on July 2, 2012, 224 days after receiving the submission on November 21, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number	K113435 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2011
Decision Date	July 02, 2012
Days to Decision	224 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF