DJP · Class II · 21 CFR 862.3100

FDA Product Code DJP: Radioimmunoassay, Amphetamine

Leading manufacturers include Hoffmann-La Roche, Inc., Roche Diagnostic Systems, Inc. and Diagnostic Products Corp..

9
Total
9
Cleared
53d
Avg days
1982
Since

FDA 510(k) Cleared Radioimmunoassay, Amphetamine Devices (Product Code DJP)

9 devices
1–9 of 9
Cleared Mar 18, 1996
PRIMIDONE EIA TEST
K960526
Diagnostic Reagents, Inc.
Toxicology · 41d
Cleared Sep 25, 1991
URINE AMPHETAMINE DIRECT RIA KIT (I-125)
K913866
Immunalysis Corporation
Toxicology · 29d
Cleared Aug 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE
K912755
Roche Diagnostic Systems, Inc.
Toxicology · 66d
Cleared Aug 08, 1988
REVISED DOUBLE ANTIBODY AMPHETAMINE
K882228
Diagnostic Products Corp.
Toxicology · 81d
Cleared Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES
K881817
Roche Diagnostic Systems, Inc.
Toxicology · 92d
Cleared Oct 15, 1985
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP
K854009
Roche Diagnostic Systems, Inc.
Toxicology · 15d
Cleared Mar 24, 1983
ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE
K830482
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Nov 29, 1982
ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE
K823212
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 22, 1982
AGGLUTEX AMPHETAMINE TEST KIT
K812986
Hoffmann-La Roche, Inc.
Toxicology · 88d

About Product Code DJP - Regulatory Context