Cleared Traditional

S-TEST CREATININE (CRE)

K080073 · Alfa Wassermann, Inc. · Chemistry
Jun 2008
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K080073 is an FDA 510(k) clearance for the S-TEST CREATININE (CRE), a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by Alfa Wassermann, Inc. (West Caldwell, US). The FDA issued a Cleared decision on June 30, 2008, 171 days after receiving the submission on January 11, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K080073 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2008
Decision Date June 30, 2008
Days to Decision 171 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFY — Enzymatic Method, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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