KLT — Enzyme Immunoassay, Carbamazepine Class II
FDA product code KLT covers "Enzyme Immunoassay, Carbamazepine", a Class II medical device regulated under 21 CFR 862.3645. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| K993028 | syva | ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90 | January 27, 2000 |
| K993987 | syva | SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL | 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 |