KLR — Enzyme Immunoassay, Lidocaine Class II
FDA product code KLR covers "Enzyme Immunoassay, Lidocaine", a Class II medical device regulated under 21 CFR 862.3555. Submissions are reviewed by the Clinical Toxicology panel. At least 17 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KLR
- Device Class
- Class II
- Regulation Number
- 862.3555
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K090282 | thermo fisher scientific | QMS LIDOCAINE | May 29, 2009 |
| K033809 | dade behring | DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRA | February 20, 2004 |
| K032334 | roche diagnostics | ROCHE ONLINE TDM LIDOCAINE | January 12, 2004 |
| K973102 | diagnostic reagents | LIDOCAINE EIA ASSAY | September 12, 1997 |
| K881116 | diagnostic systems | EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 | June 20, 1988 |
| K853010 | roche diagnostic systems | COBAS REAGENT FOR LIDOCAINE & CALIBRATORS | August 7, 1985 |
| K843184 | american dade | STRATUS LIDOCAINE FLUOROMETRIC ENZYME | September 26, 1984 |
| K833381 | e.i. dupont de nemours and co | VALPROIC ACID ANALYTICAL TEST PACK | December 27, 1983 |
| K833379 | e.i. dupont de nemours and co | LIDOCAINE ANALYTICAL TEST PACK ACA | December 27, 1983 |
| K833623 | syva | MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY | December 8, 1983 |
| K832799 | syva | MODIFICA- OF EMIT CAD LIDOCAINE ASSAY | October 14, 1983 |
| K831354 | syva | EMIT QST LIDOCAINE ASSAY | May 27, 1983 |
| K823887 | syva | ADVANCE EMIT CAD DISOPYRAMIDE ASSAY | January 28, 1983 |
| K823866 | syva | ADVANCE EMIT CAD LIDOCAINE ASSAY | January 12, 1983 |
| K822347 | american diagnostic | LIDOCAINE FLUORESCENT IMMUNOASSAY | August 25, 1982 |
| K802131 | abbott laboratories | CYBREX LIDOCAINE | October 31, 1980 |
| K801204 | syva | EMIT DISOPYRAMIDE ASSAY | June 9, 1980 |