Cleared Traditional

COCAINE KIT, TOXI-PAK

K760401 · J.T. Baker Chemical Co. · Toxicology
Aug 1976
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K760401 is an FDA 510(k) clearance for the COCAINE KIT, TOXI-PAK, a Hemagglutination, Cocaine Metabolites (benzoylecgnonine) (Class II — Special Controls, product code DLN), submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on August 26, 1976, 20 days after receiving the submission on August 6, 1976. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K760401 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 1976
Decision Date August 26, 1976
Days to Decision 20 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