DOE · Class II · 21 CFR 862.3640

FDA Product Code DOE: Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep.

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

12
Total
12
Cleared
124d
Avg days
1983
Since

FDA 510(k) Cleared Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. Devices (Product Code DOE)

12 devices
1–12 of 12
Cleared Jun 01, 1995
ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION
K951319
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 09, 1994
ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)
K935055
Roche Diagnostic Systems, Inc.
Toxicology · 293d
Cleared Mar 19, 1987
THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT
K863913
Diagnostic Products Corp.
Toxicology · 162d
Cleared Mar 16, 1987
MORPHINE ROCHE (R) EIA TEST
K864168
Roche Diagnostic Systems, Inc.
Toxicology · 143d

About Product Code DOE - Regulatory Context