Cleared Traditional

ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES

K881816 · Roche Diagnostic Systems, Inc. · Toxicology

Jul 1988

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K881816 is an FDA 510(k) clearance for the ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES, a Radioimmunoassay, Barbiturate (Class II — Special Controls, product code DKN), submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on July 28, 1988, 91 days after receiving the submission on April 28, 1988. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number	K881816 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 1988
Decision Date	July 28, 1988
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—