WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA— 510(k) K013101

Name: FDA 510(k) clearance K013101
Creator: U.S. Food and Drug Administration
Published: 2001-11-16

Substantially Equivalent

Wiener Laboratories Saic

FDA 510(k) clearance K013101 for WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA, Substantially Equivalent on 2001-11-16. Applicant: Wiener Laboratories Saic. Device class: 2.

Clearance details

Applicant: Wiener Laboratories Saic
Product code: Code JFJ
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 2001-09-17
Decision date: 2001-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosario, Santa Fe, AR

Download summary PDF View on FDA.gov ↗

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