KLT · Class II · 21 CFR 862.3645

FDA Product Code KLT: Enzyme Immunoassay, Carbamazepine

Leading manufacturers include Syva Co., Abbott Laboratories and Beckman Instruments, Inc..

56
Total
56
Cleared
82d
Avg days
1978
Since
56 devices
25–48 of 56
Cleared Feb 12, 1982
CARBAMAZEPINE ASSAY
K820189
Syva Co.
Toxicology · 18d
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