KLT · Class II · 21 CFR 862.3645

FDA Product Code KLT: Enzyme Immunoassay, Carbamazepine

Leading manufacturers include Syva Co., Abbott Laboratories and Miles Laboratories, Inc..

56
Total
56
Cleared
82d
Avg days
1978
Since
56 devices
49–56 of 56
Cleared May 09, 1983
CARBAMEZEPINE REAGENT TEST KIT
K831222
Beckman Instruments, Inc.
Chemistry · 24d
Cleared Jul 16, 1982
CARBAMAZEPINE FLOURESCENT IMMUNOASSAY
K821945
American Diagnostic Corp.
Toxicology · 17d
Cleared Feb 12, 1982
CARBAMAZEPINE ASSAY
K820189
Syva Co.
Toxicology · 18d
Cleared Jul 15, 1981
AMES TDA CARBAMAZEPINE TEST
K811952
Miles Laboratories, Inc.
Toxicology · 8d
Cleared Dec 19, 1980
CYBREX CARBAMAZEPINE
K802902
Abbott Laboratories
Immunology · 32d
Cleared Mar 02, 1979
EMIT AED ASSAYS 3500 COMPUTER DIRECTED
K790255
Syva Co.
Toxicology · 24d
Cleared Jan 10, 1979
ANALYTICAL TEST PACK, CARBAMAZEPINE
K781958
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 50d
Cleared Apr 24, 1978
EMIT CARBAMAZEPINE ASSAY
K780466
Syva Co.
Toxicology · 33d