KLN · Class II · 21 CFR 862.3250

FDA Product Code KLN: Radioimmunoassay, Cocaine Metabolite

Leading manufacturers include Roche Diagnostic Systems, Inc., Diagnostic Products Corp. and Immunalysis Corporation.

14
Total
14
Cleared
64d
Avg days
1983
Since

FDA 510(k) Cleared Radioimmunoassay, Cocaine Metabolite Devices (Product Code KLN)

14 devices
1–14 of 14
Cleared Sep 19, 1991
URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)
K913867
Immunalysis Corporation
Toxicology · 23d
Cleared Sep 10, 1991
ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE
K913722
Roche Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Jul 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE
K912756
Roche Diagnostic Systems, Inc.
Toxicology · 35d
Cleared Mar 19, 1991
TARGET COCAINE METABOLITE-R
K910122
V-Tech, Inc.
Immunology · 67d
Cleared Mar 19, 1991
TARGET COCAINE METABOLITE-V
K910123
V-Tech, Inc.
Toxicology · 67d
Cleared Feb 13, 1991
MILENIA COCAINE METABOLITE
K910044
Diagnostic Products Corp.
Toxicology · 40d
Cleared Jan 15, 1991
ABUSCREEN ONTRAK FOR COCAINE (200NG/ML)
K905730
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Nov 28, 1990
ABUSCREEN ONLINE TM FOR COCAINE METABOLITE
K904995
Roche Diagnostic Systems, Inc.
Toxicology · 21d
Cleared Jun 16, 1987
RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]
K871549
Immunalysis Corporation
Chemistry · 63d
Cleared Mar 19, 1987
COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5
K870740
Diagnostic Products Corp.
Toxicology · 22d
Cleared Jun 27, 1986
DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT
K862218
Diagnostic Products Corp.
Chemistry · 16d
Cleared Mar 24, 1983
ABUSCREEN RADIOIMMUNOASSAY-COCAINE META
K830480
Hoffmann-La Roche, Inc.
Toxicology · 37d

About Product Code KLN - Regulatory Context