Cleared Traditional

ON*SITE ALCOHOL

K923337 · Toxi-Lab, Inc. · Toxicology
Jan 1993
Decision
208d
Days
Class 2
Risk

About This 510(k) Submission

K923337 is an FDA 510(k) clearance for the ON*SITE ALCOHOL, a Nad-nadh, Specific Reagent For Alcohol Enzyme Method (Class II — Special Controls, product code DML), submitted by Toxi-Lab, Inc. (Irvine, US). The FDA issued a Cleared decision on January 12, 1993, 208 days after receiving the submission on June 18, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number K923337 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1992
Decision Date January 12, 1993
Days to Decision 208 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DML — Nad-nadh, Specific Reagent For Alcohol Enzyme Method
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3040

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