Product code KLR
- Device name
- Enzyme Immunoassay, Lidocaine
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3555
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K090282 | QMS LIDOCAINE | Thermo Fisher Scientific, Inc. | 2009-05-29 |
| K033809 | DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D | Dade Behring, Inc. | 2004-02-20 |
| K032334 | ROCHE ONLINE TDM LIDOCAINE | Roche Diagnostics Corp. | 2004-01-12 |
| K973102 | LIDOCAINE EIA ASSAY | Diagnostic Reagents, Inc. | 1997-09-12 |
| K881116 | EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 | Diagnostic Systems | 1988-06-20 |
| K853010 | COBAS REAGENT FOR LIDOCAINE & CALIBRATORS | Roche Diagnostic Systems, Inc. | 1985-08-07 |
| K843184 | STRATUS LIDOCAINE FLUOROMETRIC ENZYME | American Dade | 1984-09-26 |
| K833379 | LIDOCAINE ANALYTICAL TEST PACK ACA | E.I. Dupont DE Nemours & Co., Inc. | 1983-12-27 |
| K833381 | VALPROIC ACID ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1983-12-27 |
| K833623 | MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY | Syva Co. | 1983-12-08 |
| K832799 | MODIFICA- OF EMIT CAD LIDOCAINE ASSAY | Syva Co. | 1983-10-14 |
| K831354 | EMIT QST LIDOCAINE ASSAY | Syva Co. | 1983-05-27 |
| K823887 | ADVANCE EMIT CAD DISOPYRAMIDE ASSAY | Syva Co. | 1983-01-28 |
| K823866 | ADVANCE EMIT CAD LIDOCAINE ASSAY | Syva Co. | 1983-01-12 |
| K822347 | LIDOCAINE FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1982-08-25 |
| K802131 | CYBREX LIDOCAINE | Abbott Laboratories | 1980-10-31 |
| K801204 | EMIT DISOPYRAMIDE ASSAY | Syva Co. | 1980-06-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414220680 | Atellica CH LIDO | Siemens Healthcare Diagnostics Inc. | 2018-10-08 |
| 00842768001390 | Syva® Emit® Lidocaine Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001406 | Syva® Emit® Disopyramide Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768005305 | Dimension® Flex® reagent cartridge LIDO | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768015281 | Dimension Vista® Flex® reagent cartridge LIDO | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00884883006072 | QMS Lidocaine Immunoassay | Microgenics Corporation | 2016-09-22 |
| 04015630915736 | Lidocaine | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630996933 | ONLINE TDM Lidocaine | Roche Diagnostics GmbH | 2016-09-20 |