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 |