Panels › Clinical Toxicology › Product code KLT · Class 2
Enzyme Immunoassay, Carbamazepine
Regulation 862.3645
0510(k)s in 12 months (56 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in KLT
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2015 | K151578 | Carbamazepine Gen 4 Roche Diagnostics Operations (Rdo) | KLT |
| Jun 5, 2013 | K123518 | ABBOTT CARBAMAZEPINE ASSAY Microgenics Corporation | KLT |
| Oct 14, 2011 | K103627 | ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS Abbott Laboratories | KLT |
| Oct 5, 2007 | K063131 | CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS Thermo Electron OY, FI | KLT |
| Feb 8, 2005 | K042808 | ADVIA IMS CARBAMAZEPINE METHOD Bayer Healthcare, LLC | KLT |
| Sep 17, 2003 | K031902 | ONLINE TDM CARBAMAZEPINE Roche Diagnostics Corp. | KLT |
| Jan 15, 2002 | K011648 | RANDOX CARBAMAZEPINE Randox Laboratories, Ltd., GB | KLT |
| Apr 13, 2001 | K010814 | EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 Syva Co., Dade Behring, Inc. | KLT |
| May 18, 2000 | K000903 | ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM Bayer Corp. | KLT |
| Feb 28, 2000 | K000007 | IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6 Diagnostic Products Corp. | KLT |
| Jan 27, 2000 | K993987 | SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL Syva Co. | KLT |
| Jan 27, 2000 | K993028 | ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90 Syva Co. | KLT |
| Feb 25, 1998 | K980283 | VITROS CHEMISTRY PRODUCTS CRBM SLIDES Johnson & Johnson Clinical Diagnostics, Inc. | KLT |
| Oct 20, 1997 | K973535 | ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS Schiapparelli Biosystems, Inc. | KLT |
| Feb 14, 1997 | K964765 | CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY Chiron Diagnostics Corp. | KLT |
| Feb 4, 1997 | K963673 | IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS Beckman Instruments, Inc. | KLT |
| Dec 13, 1996 | K964068 | CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM Bayer Corp. | KLT |
| Sep 13, 1996 | K962820 | CARBAMAZEPINE FLEX REAGENT CARTRIDGE Dade Intl., Inc. | KLT |
| Feb 16, 1996 | K955644 | SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM Beckman Instruments, Inc. | KLT |
| Dec 13, 1995 | K955100 | CARBAMAZEPINE EIA TEST Diagnostic Reagents, Inc. | KLT |
| Jan 25, 1995 | K942687 | IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00 Instrumentation Laboratory CO | KLT |
| Jun 21, 1994 | K935374 | AXSYM CARBAMAZEPHINE Abbott Laboratories | KLT |
| Jun 2, 1994 | K940374 | QMS CARBAMAZEPINE ASSAY Seradyn, Inc. | KLT |
| Oct 1, 1993 | K933684 | IL TEST CARBAMAZEPHINE Instrumentation Laboratory CO | KLT |
| May 26, 1993 | K926441 | ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI Roche Diagnostic Systems, Inc. | KLT |
| Jul 23, 1992 | K915756 | BIOTRACK CARBAMAZEPINE TEST CARTRIDGE Biotrack, Inc. | KLT |
| Jan 15, 1992 | K914857 | CEDIA(R) CARBAMAZEPINE ASSAY Microgenics Corp. | KLT |
| Jul 30, 1991 | K913066 | EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS Syva Co. | KLT |
| Mar 30, 1990 | K901086 | ENZYMUN TEST(R) T4 (TOTAL THYROXINE) Boehringer Mannheim Corp. | KLT |
| Jan 18, 1990 | K897114 | EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY Syva Co. | KLT |
| Jan 2, 1990 | K896860 | OPUS CARBAMAZEPINE TEST SYSTEM Pb Diagnostic Systems, Inc. | KLT |
| Aug 28, 1989 | K894519 | FPR CARBAMAZEPINE KIT Colony Laboratories, Inc. | KLT |
| Aug 11, 1989 | K893507 | INNOFLUOR CARBAMAZEPINE REAGENT SET Innotron of Oregon, Inc. | KLT |
| Aug 29, 1988 | K882961 | EMIT QST CARBAMAZEPINE ASSAY Syva Co. | KLT |
| Sep 22, 1987 | K873282 | CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY Windsor Laboratories, Inc. | KLT |
| Jun 17, 1987 | K871254 | ACCULEVEL CARBAMAZEPINE TEST Syva Co. | KLT |
| Apr 14, 1987 | K871306 | EMIT CARBAMAZEPINE ASSAY Syva Co. | KLT |
| Jan 14, 1987 | K863842 | SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT Miles Laboratories, Inc. | KLT |
| Jan 8, 1987 | K864553 | EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95 Em Diagnostic Systems, Inc. | KLT |
| Jan 7, 1987 | K862916 | EZ-SCREEN: CANNABINOID Environmental Diagnostics, Inc. | KLT |
| Jan 22, 1986 | K860047 | DETERMINATION OF CARBAMAZEPINE Clinical Data, Inc. | KLT |
| Oct 1, 1985 | K853835 | EMIT QST CARBAMAZEPINE ASSAY Syva Co. | KLT |
| Mar 22, 1985 | K850807 | COBAS FP REAGENTS FOR CARBAMAZEPINE Roche Diagnostic Systems, Inc. | KLT |
| Jan 24, 1984 | K834052 | CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT Abbott Laboratories | KLT |
| Oct 4, 1983 | K832720 | EMIT AED CARBAMAZEPINE ASSAY Syva Co. | KLT |
| Sep 29, 1983 | K832766 | AMES TDA DISOPYRAMIDE TEST Miles Laboratories, Inc. | KLT |
| Sep 12, 1983 | K832631 | A-GENT CARBAMAZEPINE Abbott Laboratories | KLT |
| Sep 12, 1983 | K832447 | STRATUS CARBAMAZEPINE FLUROMETRIC American Dade | KLT |
| May 9, 1983 | K831222 | CARBAMEZEPINE REAGENT TEST KIT Beckman Instruments, Inc. | KLT |
| Jul 16, 1982 | K821945 | CARBAMAZEPINE FLOURESCENT IMMUNOASSAY American Diagnostic Corp. | KLT |
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