Cleared Traditional

SIGMA PROCEDURE NO. 333-UV

K914777 · Sigma Diagnostics, Inc. · Toxicology
Dec 1991
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K914777 is an FDA 510(k) clearance for the SIGMA PROCEDURE NO. 333-UV, a Nad-nadh, Specific Reagent For Alcohol Enzyme Method (Class II — Special Controls, product code DML), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on December 27, 1991, 65 days after receiving the submission on October 23, 1991. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number K914777 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 1991
Decision Date December 27, 1991
Days to Decision 65 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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