DLN · Class II · 21 CFR 862.3250

FDA Product Code DLN: Hemagglutination, Cocaine Metabolites (benzoylecgnonine)

Leading manufacturers include J.T. Baker Chemical Co., Roche Diagnostic Systems, Inc. and E.I. Dupont DE Nemours & Co., Inc..

4
Total
4
Cleared
58d
Avg days
1976
Since

FDA 510(k) Cleared Hemagglutination, Cocaine Metabolites (benzoylecgnonine) Devices (Product Code DLN)

4 devices
1–4 of 4
Cleared Mar 21, 1995
URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE
K950134
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 67d
Cleared Dec 28, 1992
ABUSCREEN ONLINE FOR COCAINE METABOLITE
K924113
Roche Diagnostic Systems, Inc.
Toxicology · 137d
Cleared Aug 26, 1976
COCAINE KIT, TOXI-PAK
K760401
J.T. Baker Chemical Co.
Toxicology · 20d

About Product Code DLN - Regulatory Context