510(k) K853010
- Device
- COBAS REAGENT FOR LIDOCAINE & CALIBRATORS
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K853010
- Product code
- KLR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-08-07
- Date received
- 1985-07-16
- Regulation
- 862.3555
- Classification name
- Enzyme Immunoassay, Lidocaine
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAFADER II
- Address
- 11 Franklin Ave. Belleville NJ US 07109 07109
FDA Registration Numbers#
- 3010939897
- 3010825766
- 2517506
- 9610126
- 2432235
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KLR #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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