WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354— 510(k) K023744

Name: FDA 510(k) clearance K023744
Creator: U.S. Food and Drug Administration
Published: 2003-01-03

Substantially Equivalent

Wiener Laboratories Saic

FDA 510(k) clearance K023744 for WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354, Substantially Equivalent on 2003-01-03. Applicant: Wiener Laboratories Saic. Device class: 2.

Clearance details

Applicant: Wiener Laboratories Saic
Product code: Code JHW
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2002-11-07
Decision date: 2003-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosario, Santa Fe, AR

Download summary PDF View on FDA.gov ↗

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