Cleared Traditional

ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP

K854009 · Roche Diagnostic Systems, Inc. · Toxicology
Oct 1985
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K854009 is an FDA 510(k) clearance for the ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP, a Radioimmunoassay, Amphetamine (Class II — Special Controls, product code DJP), submitted by Roche Diagnostic Systems, Inc. (Belleville, US). The FDA issued a Cleared decision on October 15, 1985, 15 days after receiving the submission on September 30, 1985. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K854009 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 1985
Decision Date October 15, 1985
Days to Decision 15 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

Similar Devices — DJP Radioimmunoassay, Amphetamine

All 8
PRIMIDONE EIA TEST
K960526 · Diagnostic Reagents, Inc. · Mar 1996
URINE AMPHETAMINE DIRECT RIA KIT (I-125)
K913866 · Immunalysis Corporation · Sep 1991
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE
K912755 · Roche Diagnostic Systems, Inc. · Aug 1991
REVISED DOUBLE ANTIBODY AMPHETAMINE
K882228 · Diagnostic Products Corp. · Aug 1988
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES
K881817 · Roche Diagnostic Systems, Inc. · Jul 1988
ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE
K830482 · Hoffmann-La Roche, Inc. · Mar 1983