Cleared Traditional

K760075 - KIT, METHADONE (TOXI-PAK IMMUNO HI)
(FDA 510(k) Clearance)

K760075 · J.T. Baker Chemical Co. · Toxicology
Jul 1976
Decision
32d
Days
Class 2
Risk

K760075 is an FDA 510(k) clearance for the KIT, METHADONE (TOXI-PAK IMMUNO HI), a Hemagglutination Inhibition, Methadone (Class II — Special Controls, product code DIW), submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1976, 32 days after receiving the submission on June 18, 1976. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K760075 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1976
Decision Date July 20, 1976
Days to Decision 32 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DIW — Hemagglutination Inhibition, Methadone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3620