Cleared Traditional

HI-M-TEST FOR METHADONE TEST #2

K801509 · Technam, Inc. · Toxicology

Jul 1980

Decision

14d

Days

Class 2

Risk

About This 510(k) Submission

K801509 is an FDA 510(k) clearance for the HI-M-TEST FOR METHADONE TEST #2, a Hemagglutination Inhibition, Methadone (Class II — Special Controls, product code DIW), submitted by Technam, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1980, 14 days after receiving the submission on June 30, 1980. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number	K801509 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 1980
Decision Date	July 14, 1980
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—