Cleared Traditional

ROCHE ABUSCREEN ONTRAK FOR METHADONE

K930845 · Roche Diagnostic Systems, Inc. · Toxicology

Apr 1993

Decision

61d

Days

Class 2

Risk

About This 510(k) Submission

K930845 is an FDA 510(k) clearance for the ROCHE ABUSCREEN ONTRAK FOR METHADONE, a Hemagglutination Inhibition, Methadone (Class II — Special Controls, product code DIW), submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on April 20, 1993, 61 days after receiving the submission on February 18, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number	K930845 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 18, 1993
Decision Date	April 20, 1993
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement