Cleared Traditional

ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE

K123018 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry
Apr 2013
Decision
207d
Days
Class 2
Risk

About This 510(k) Submission

K123018 is an FDA 510(k) clearance for the ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on April 23, 2013, 207 days after receiving the submission on September 28, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K123018 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2012
Decision Date April 23, 2013
Days to Decision 207 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CFR — Hexokinase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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