Cleared Traditional

ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES

K881817 · Roche Diagnostic Systems, Inc. · Toxicology
Jul 1988
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K881817 is an FDA 510(k) clearance for the ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES, a Radioimmunoassay, Amphetamine (Class II — Special Controls, product code DJP), submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on July 29, 1988, 92 days after receiving the submission on April 28, 1988. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K881817 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1988
Decision Date July 29, 1988
Days to Decision 92 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DJP — Radioimmunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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