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 22, 2015
Carbamazepine Gen 4
K151578
Roche Diagnostics Operations (Rdo)
Toxicology · 133d
Cleared Jun 05, 2013
ABBOTT CARBAMAZEPINE ASSAY
K123518
Microgenics Corporation
Toxicology · 203d
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 Apr 13, 2001
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
K010814
Syva Co., Dade Behring, Inc.
Toxicology · 25d
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 25, 1998
VITROS CHEMISTRY PRODUCTS CRBM SLIDES
K980283
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 30d
Cleared Oct 20, 1997
ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS
K973535
Schiapparelli Biosystems, Inc.
Chemistry · 32d
Cleared Feb 14, 1997
CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY
K964765
Chiron Diagnostics Corp.
Toxicology · 79d
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 Sep 13, 1996
CARBAMAZEPINE FLEX REAGENT CARTRIDGE
K962820
Dade Intl., Inc.
Toxicology · 56d
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 Jun 02, 1994
QMS CARBAMAZEPINE ASSAY
K940374
Seradyn, Inc.
Toxicology · 127d
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

About Product Code KLT - Regulatory Context