FDA 510(k) Applications for Medical Device Product Code "KLT"
(Enzyme Immunoassay, Carbamazepine)

FDA 510(k) Number Applicant Device Name Decision Date
K103627 ABBOTT LABORATORIES ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS 10/14/2011
K000903 BAYER CORP. ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM 05/18/2000
K964068 BAYER CORP. CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM 12/13/1996
K042808 BAYER HEALTHCARE, LLC ADVIA IMS CARBAMAZEPINE METHOD 02/08/2005
K963673 BECKMAN INSTRUMENTS, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS 02/04/1997
K955644 BECKMAN INSTRUMENTS, INC. SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM 02/16/1996
K964765 CHIRON DIAGNOSTICS CORP. CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY 02/14/1997
K962820 DADE INTL., INC. CARBAMAZEPINE FLEX REAGENT CARTRIDGE 09/13/1996
K000007 DIAGNOSTIC PRODUCTS CORP. IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6 02/28/2000
K980283 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CRBM SLIDES 02/25/1998
K123518 Microgenics Corporation ABBOTT CARBAMAZEPINE ASSAY 06/05/2013
K011648 RANDOX LABORATORIES, LTD. RANDOX CARBAMAZEPINE 01/15/2002
K031902 ROCHE DIAGNOSTICS CORP. ONLINE TDM CARBAMAZEPINE 09/17/2003
K151578 Roche Diagnostics Operations (RDO) Carbamazepine Gen 4 10/22/2015
K973535 SCHIAPPARELLI BIOSYSTEMS, INC. ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS 10/20/1997
K993028 SYVA CO. ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90 01/27/2000
K993987 SYVA CO. SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL 01/27/2000
K010814 SYVA CO., DADE BEHRING, INC. EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 04/13/2001
K063131 THERMO ELECTRON OY CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS 10/05/2007


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