Cleared Traditional

URINE AMPHETAMINE DIRECT RIA KIT (I-125)

K913866 · Immunalysis Corporation · Toxicology
Sep 1991
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K913866 is an FDA 510(k) clearance for the URINE AMPHETAMINE DIRECT RIA KIT (I-125), a Radioimmunoassay, Amphetamine (Class II — Special Controls, product code DJP), submitted by Immunalysis Corporation (Glendale, US). The FDA issued a Cleared decision on September 25, 1991, 29 days after receiving the submission on August 27, 1991. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K913866 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1991
Decision Date September 25, 1991
Days to Decision 29 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

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
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 FOR AMPHETAMINE-HIGH SP
K854009 · Roche Diagnostic Systems, Inc. · Oct 1985
ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE
K830482 · Hoffmann-La Roche, Inc. · Mar 1983