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 May 26, 1993
ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI
K926441
Roche Diagnostic Systems, Inc.
Chemistry · 154d
Cleared Jul 23, 1992
BIOTRACK CARBAMAZEPINE TEST CARTRIDGE
K915756
Biotrack, Inc.
Toxicology · 213d
Cleared Jan 15, 1992
CEDIA(R) CARBAMAZEPINE ASSAY
K914857
Microgenics Corp.
Toxicology · 78d
Cleared Jul 30, 1991
EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS
K913066
Syva Co.
Toxicology · 20d
Cleared Mar 30, 1990
ENZYMUN TEST(R) T4 (TOTAL THYROXINE)
K901086
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Jan 18, 1990
EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY
K897114
Syva Co.
Toxicology · 23d
Cleared Jan 02, 1990
OPUS CARBAMAZEPINE TEST SYSTEM
K896860
Pb Diagnostic Systems, Inc.
Toxicology · 28d
Cleared Aug 28, 1989
FPR CARBAMAZEPINE KIT
K894519
Colony Laboratories, Inc.
Toxicology · 39d
Cleared Aug 11, 1989
INNOFLUOR CARBAMAZEPINE REAGENT SET
K893507
Innotron of Oregon, Inc.
Chemistry · 98d
Cleared Aug 29, 1988
EMIT QST CARBAMAZEPINE ASSAY
K882961
Syva Co.
Toxicology · 46d
Cleared Sep 22, 1987
CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY
K873282
Windsor Laboratories, Inc.
Toxicology · 36d
Cleared Jun 17, 1987
ACCULEVEL CARBAMAZEPINE TEST
K871254
Syva Co.
Toxicology · 79d
Cleared Apr 14, 1987
EMIT CARBAMAZEPINE ASSAY
K871306
Syva Co.
Toxicology · 13d
Cleared Jan 14, 1987
SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT
K863842
Miles Laboratories, Inc.
Toxicology · 105d
Cleared Jan 08, 1987
EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95
K864553
Em Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Jan 07, 1987
EZ-SCREEN: CANNABINOID
K862916
Environmental Diagnostics, Inc.
Toxicology · 159d
Cleared Jan 22, 1986
DETERMINATION OF CARBAMAZEPINE
K860047
Clinical Data, Inc.
Toxicology · 16d
Cleared Oct 01, 1985
EMIT QST CARBAMAZEPINE ASSAY
K853835
Syva Co.
Toxicology · 15d
Cleared Mar 22, 1985
COBAS FP REAGENTS FOR CARBAMAZEPINE
K850807
Roche Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Jan 24, 1984
CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT
K834052
Abbott Laboratories
Toxicology · 62d
Cleared Oct 04, 1983
EMIT AED CARBAMAZEPINE ASSAY
K832720
Syva Co.
Toxicology · 53d
Cleared Sep 29, 1983
AMES TDA DISOPYRAMIDE TEST
K832766
Miles Laboratories, Inc.
Toxicology · 44d
Cleared Sep 12, 1983
STRATUS CARBAMAZEPINE FLUROMETRIC
K832447
American Dade
Chemistry · 49d
Cleared Sep 12, 1983
A-GENT CARBAMAZEPINE
K832631
Abbott Laboratories
Toxicology · 39d