DKN · Class II · 21 CFR 862.3150

FDA Product Code DKN: Radioimmunoassay, Barbiturate

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

4
Total
4
Cleared
51d
Avg days
1981
Since

FDA 510(k) Cleared Radioimmunoassay, Barbiturate Devices (Product Code DKN)

4 devices
1–4 of 4
Cleared Oct 30, 1991
ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES
K914468
Roche Diagnostic Systems, Inc.
Toxicology · 23d
Cleared Jul 28, 1988
ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES
K881816
Roche Diagnostic Systems, Inc.
Toxicology · 91d
Cleared Mar 10, 1983
ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE
K830479
Hoffmann-La Roche, Inc.
Toxicology · 23d
Cleared Dec 31, 1981
AGGLUTEX BARBITURATES TEST KIT
K812988
Hoffmann-La Roche, Inc.
Toxicology · 66d

About Product Code DKN - Regulatory Context