Cleared Traditional

WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354

K023744 · Wiener Laboratories Saic · Chemistry
Jan 2003
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K023744 is an FDA 510(k) clearance for the WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354, a U.v. Method, Cpk Isoenzymes (Class II — Special Controls, product code JHW), submitted by Wiener Laboratories Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on January 3, 2003, 57 days after receiving the submission on November 7, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K023744 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2002
Decision Date January 03, 2003
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JHW — U.v. Method, Cpk Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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