Cleared Traditional

S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST

K072142 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry

Jun 2008

Decision

329d

Days

Class 2

Risk

About This 510(k) Submission

K072142 is an FDA 510(k) clearance for the S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST, a Phenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CKF), submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on June 26, 2008, 329 days after receiving the submission on August 2, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number	K072142 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 2007
Decision Date	June 26, 2008
Days to Decision	329 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF