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

FDA 510(k) Cleared Enzyme Immunoassay, Carbamazepine Devices (Product Code KLT)

56 devices
1–24 of 56
Cleared Oct 14, 2011
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS
K103627
Abbott Laboratories
Toxicology · 305d
Cleared Sep 17, 2003
ONLINE TDM CARBAMAZEPINE
K031902
Roche Diagnostics Corp.
Toxicology · 89d
Cleared Feb 28, 2000
IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6
K000007
Diagnostic Products Corp.
Toxicology · 56d
Cleared Jan 27, 2000
ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS
K993028
Syva Co.
Toxicology · 140d
Cleared Jan 27, 2000
SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL
K993987
Syva Co.
Toxicology · 64d
Cleared Feb 04, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
K963673
Beckman Instruments, Inc.
Chemistry · 144d
Cleared Feb 16, 1996
SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM
K955644
Beckman Instruments, Inc.
Immunology · 66d
Cleared Jan 25, 1995
IL TEST CARBAMAZEPINE, PN 181754-00
K942687
Instrumentation Laboratory CO
Toxicology · 232d
Cleared Jun 21, 1994
AXSYM CARBAMAZEPHINE
K935374
Abbott Laboratories
Toxicology · 225d
Cleared Oct 01, 1993
IL TEST CARBAMAZEPHINE
K933684
Instrumentation Laboratory CO
Toxicology · 64d
Cleared May 26, 1993
ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI
K926441
Roche Diagnostic Systems, Inc.
Chemistry · 154d
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 Aug 29, 1988
EMIT QST CARBAMAZEPINE ASSAY
K882961
Syva Co.
Toxicology · 46d
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 08, 1987
EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95
K864553
Em Diagnostic Systems, Inc.
Toxicology · 50d
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 12, 1983
A-GENT CARBAMAZEPINE
K832631
Abbott Laboratories
Toxicology · 39d
Cleared May 09, 1983
CARBAMEZEPINE REAGENT TEST KIT
K831222
Beckman Instruments, Inc.
Chemistry · 24d

About Product Code KLT - Regulatory Context