Cleared Traditional

S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023

K091711 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry
Dec 2009
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K091711 is an FDA 510(k) clearance for the S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023, 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 December 11, 2009, 184 days after receiving the submission on June 10, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K091711 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2009
Decision Date December 11, 2009
Days to Decision 184 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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