DLZ · Class II · 21 CFR 862.3660

FDA Product Code DLZ: Enzyme Immunoassay, Phenobarbital

Leading manufacturers include Syva Co., Abbott Laboratories and Em Diagnostic Systems, Inc..

35
Total
35
Cleared
76d
Avg days
1977
Since
35 devices
25–35 of 35
Cleared Jan 30, 1984
CHEM KIT PHENOBARBITAL
K833796
Abbott Laboratories
Toxicology · 90d
Cleared Jan 24, 1984
EMIT QST PHENOBARBITAL ASSAY
K834216
Syva Co.
Toxicology · 50d
Cleared Sep 12, 1983
A-GENT PHENOBARBITAL
K832457
Abbott Laboratories
Toxicology · 48d
Cleared Aug 11, 1983
PHENOBARTIAL ASSAY USE ON COBAS-BIO
K832097
Syva Co.
Chemistry · 43d
Cleared Jun 25, 1981
EMIT-ST SERUM PHENOBARBITAL ASSAY
K811621
Syva Co.
Toxicology · 17d
Cleared May 29, 1981
KALLESTAD ANTISERA TO PHENOBARBITAL
K811367
Kallestad Laboratories, Inc.
Chemistry · 15d
Cleared Oct 23, 1980
PHENOBARBITAL REAGENT TEST KIT
K802039
Beckman Instruments, Inc.
Toxicology · 59d
Cleared Jun 22, 1977
PHENOBARBITAL ANALYTICAL TEST PACKS
K770919
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 34d