WIENER LAB AMILASA 405 AA LIQUIDA— 510(k) K023549

Name: FDA 510(k) clearance K023549
Creator: U.S. Food and Drug Administration
Published: 2002-12-09

Substantially Equivalent

Wiener Laboratories Saic

FDA 510(k) clearance K023549 for WIENER LAB AMILASA 405 AA LIQUIDA, Substantially Equivalent on 2002-12-09. 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: 2002-10-22
Decision date: 2002-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosario, Santa Fe, AR

Download summary PDF View on FDA.gov ↗

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