Cleared Traditional

WIENER LAB AMILASA 405 AA LIQUIDA

K023549 · Wiener Laboratories Saic · Chemistry
Dec 2002
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K023549 is an FDA 510(k) clearance for the WIENER LAB AMILASA 405 AA LIQUIDA, a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Wiener Laboratories Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on December 9, 2002, 48 days after receiving the submission on October 22, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K023549 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2002
Decision Date December 09, 2002
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFJ — Catalytic Methods, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070

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