Cleared Traditional

HIM TEST COCAINE

K792429 · Tecknam, Inc. · Toxicology
Dec 1979
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K792429 is an FDA 510(k) clearance for the HIM TEST COCAINE, a Hemagglutination, Cocaine Metabolites (benzoylecgnonine) (Class II — Special Controls, product code DLN), submitted by Tecknam, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 7, 1979, 9 days after receiving the submission on November 28, 1979. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K792429 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 1979
Decision Date December 07, 1979
Days to Decision 9 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DLN — Hemagglutination, Cocaine Metabolites (benzoylecgnonine)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250