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

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 Feb 08, 2005
ADVIA IMS CARBAMAZEPINE METHOD
K042808
Bayer Healthcare, LLC
Chemistry · 119d
Cleared Sep 17, 2003
ONLINE TDM CARBAMAZEPINE
K031902
Roche Diagnostics Corp.
Toxicology · 89d
Cleared Jan 15, 2002
RANDOX CARBAMAZEPINE
K011648
Randox Laboratories, Ltd.
Toxicology · 231d
Cleared May 18, 2000
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
K000903
Bayer Corp.
Chemistry · 58d
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 Dec 13, 1996
CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K964068
Bayer Corp.
Toxicology · 64d
Cleared Feb 16, 1996
SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM
K955644
Beckman Instruments, Inc.
Immunology · 66d
Cleared Dec 13, 1995
CARBAMAZEPINE EIA TEST
K955100
Diagnostic Reagents, Inc.
Toxicology · 35d
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 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 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

About Product Code KLT - Regulatory Context