Cleared Traditional

S40 CLINICAL ANALYZER, S TEST ALB

K072143 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry
Jul 2008
Decision
347d
Days
Class 2
Risk

About This 510(k) Submission

K072143 is an FDA 510(k) clearance for the S40 CLINICAL ANALYZER, S TEST ALB, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on July 14, 2008, 347 days after receiving the submission on August 2, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K072143 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2007
Decision Date July 14, 2008
Days to Decision 347 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIX — Bromcresol Green Dye-binding, Albumin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1035

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