Cleared Traditional

ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT

K113436 · Alfa Wassermann · Chemistry
Jul 2012
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K113436 is an FDA 510(k) clearance for the ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Alfa Wassermann (West Caldwell, US). The FDA issued a Cleared decision on July 12, 2012, 234 days after receiving the submission on November 21, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K113436 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2011
Decision Date July 12, 2012
Days to Decision 234 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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