DIW · Class II · 21 CFR 862.3620

FDA Product Code DIW: Hemagglutination Inhibition, Methadone

Leading manufacturers include J.T. Baker Chemical Co., Technam, Inc. and Roche Diagnostic Systems, Inc..

4
Total
4
Cleared
43d
Avg days
1976
Since

FDA 510(k) Cleared Hemagglutination Inhibition, Methadone Devices (Product Code DIW)

4 devices
1–4 of 4
Cleared Mar 21, 1995
URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE
K950182
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 63d
Cleared Apr 20, 1993
ROCHE ABUSCREEN ONTRAK FOR METHADONE
K930845
Roche Diagnostic Systems, Inc.
Toxicology · 61d
Cleared Jul 14, 1980
HI-M-TEST FOR METHADONE TEST #2
K801509
Technam, Inc.
Toxicology · 14d
Cleared Jul 20, 1976
KIT, METHADONE (TOXI-PAK IMMUNO HI)
K760075
J.T. Baker Chemical Co.
Toxicology · 32d

About Product Code DIW - Regulatory Context