Cleared Traditional

ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT

K113437 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry
Aug 2012
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K113437 is an FDA 510(k) clearance for the ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on August 6, 2012, 259 days after receiving the submission on November 21, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K113437 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2011
Decision Date August 06, 2012
Days to Decision 259 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCP — Assay, Glycosylated Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7470

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