Cleared Traditional

WIENER LAB COLINESTERASA AA

K023992 · Wiener Laboratories Saic · Chemistry
Feb 2003
Decision
72d
Days
Class 1
Risk

About This 510(k) Submission

K023992 is an FDA 510(k) clearance for the WIENER LAB COLINESTERASA AA, a Colorimetry, Cholinesterase (Class I — General Controls, product code DIH), submitted by Wiener Laboratories Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on February 12, 2003, 72 days after receiving the submission on December 2, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3240.

Submission Details

510(k) Number K023992 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2002
Decision Date February 12, 2003
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DIH — Colorimetry, Cholinesterase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3240

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