Enzyme Immunoassay, Lidocaine
FDA product code KLR · Class II (moderate risk) · 21 CFR 862.3555 · Clinical Toxicology
17510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K090282 | QMS LidocaineKLR · Traditional | Thermo Fisher Scientific, Inc. | 05/29/2009SE |
| K033809 | Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II…KLR · Traditional | Dade Behring, Inc. | 02/20/2004SE |
| K032334 | Roche Online TDM LidocaineKLR · Traditional | Roche Diagnostics Corp. | 01/12/2004SE |
| K973102 | Lidocaine Eia AssayKLR · Traditional | Diagnostic Reagents, Inc. | 09/12/1997SE |
| K881116 | Easy-Test Emit(R) Lidocaine Lido Item No. 16641KLR · Traditional | Diagnostic Systems | 06/20/1988SE |
| K853010 | Cobas Reagent for Lidocaine & CalibratorsKLR · Traditional | Roche Diagnostic Systems, Inc. | 08/07/1985SE |
| K843184 | Stratus Lidocaine Fluorometric EnzymeKLR · Traditional | American Dade | 09/26/1984SE |
| K833381 | Valproic Acid Analytical Test PackKLR · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 12/27/1983SE |
| K833379 | Lidocaine Analytical Test Pack AcaKLR · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 12/27/1983SE |
| K833623 | Modif. of Emit Cad Disopyramide AssayKLR · Traditional | Syva Co. | 12/08/1983SE |
| K832799 | Modifica- of Emit Cad Lidocaine AssayKLR · Traditional | Syva Co. | 10/14/1983SE |
| K831354 | Emit QST Lidocaine AssayKLR · Traditional | Syva Co. | 05/27/1983SE |
| K823887 | Advance Emit Cad Disopyramide AssayKLR · Traditional | Syva Co. | 01/28/1983SE |
| K823866 | Advance Emit Cad Lidocaine AssayKLR · Traditional | Syva Co. | 01/12/1983SE |
| K822347 | Lidocaine Fluorescent ImmunoassayKLR · Traditional | American Diagnostic Corp. | 08/25/1982SE |
| K802131 | Cybrex LidocaineKLR · Traditional | Abbott Laboratories | 10/31/1980SE |
| K801204 | Emit Disopyramide AssayKLR · Traditional | Syva Co. | 06/09/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2880-2026 Class III | Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319ULOut-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot… | Siemens Healthcare Diagnostics, Inc. | 06/26/2026Open, Classified |