KLT — Enzyme Immunoassay, Carbamazepine Class II
FDA Device Classification
Classification Details
- Product Code
- KLT
- Device Class
- Class II
- Regulation Number
- 862.3645
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K151578 | roche diagnostics operations (rdo) | Carbamazepine Gen 4 | October 22, 2015 |
| K123518 | microgenics corporation | ABBOTT CARBAMAZEPINE ASSAY | June 5, 2013 |
| K103627 | abbott laboratories | ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIB | October 14, 2011 |
| K063131 | thermo electron | CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS | October 5, 2007 |
| K042808 | bayer healthcare | ADVIA IMS CARBAMAZEPINE METHOD | February 8, 2005 |
| K031902 | roche diagnostics | ONLINE TDM CARBAMAZEPINE | September 17, 2003 |
| K011648 | randox laboratories | RANDOX CARBAMAZEPINE | January 15, 2002 |
| K010814 | syva co., dade behring | EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 | April 13, 2001 |
| K000903 | bayer | ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM | May 18, 2000 |
| K000007 | diagnostic products | IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2 | February 28, 2000 |
| K993987 | syva | SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL | January 27, 2000 |
| K993028 | syva | ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90 | January 27, 2000 |
| K980283 | johnson and johnson clinical diagnostics | VITROS CHEMISTRY PRODUCTS CRBM SLIDES | February 25, 1998 |
| K973535 | schiapparelli biosystems | ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS | October 20, 1997 |
| K964765 | chiron diagnostics | CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY | February 14, 1997 |
| K963673 | beckman instruments | IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS | February 4, 1997 |
| K964068 | bayer | CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | December 13, 1996 |
| K962820 | dade intl | CARBAMAZEPINE FLEX REAGENT CARTRIDGE | September 13, 1996 |
| K955644 | beckman instruments | SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM | February 16, 1996 |
| K955100 | diagnostic reagents | CARBAMAZEPINE EIA TEST | December 13, 1995 |