ADVANCE EMIT CAD LIDOCAINE ASSAY
FDA 510(k) clearance K823866 · decided 1983-01-12
Clearance details
- K-number
- K823866
- Device name
- ADVANCE EMIT CAD LIDOCAINE ASSAY
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-23
- Decision date
- 1983-01-12
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- KLR
- Device class
- 2
- Regulation number
- 862.3555
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| QMS LIDOCAINE (K090282) | Thermo Fisher Scientific, Inc. | 2009-05-29 |
| DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D (K033809) | Dade Behring, Inc. | 2004-02-20 |
| ROCHE ONLINE TDM LIDOCAINE (K032334) | Roche Diagnostics Corp. | 2004-01-12 |
| LIDOCAINE EIA ASSAY (K973102) | Diagnostic Reagents, Inc. | 1997-09-12 |
| EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 (K881116) | Diagnostic Systems | 1988-06-20 |
| COBAS REAGENT FOR LIDOCAINE & CALIBRATORS (K853010) | Roche Diagnostic Systems, Inc. | 1985-08-07 |
| STRATUS LIDOCAINE FLUOROMETRIC ENZYME (K843184) | American Dade | 1984-09-26 |
| LIDOCAINE ANALYTICAL TEST PACK ACA (K833379) | E.I. Dupont DE Nemours & Co., Inc. | 1983-12-27 |
| VALPROIC ACID ANALYTICAL TEST PACK (K833381) | E.I. Dupont DE Nemours & Co., Inc. | 1983-12-27 |
| MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY (K833623) | Syva Co. | 1983-12-08 |
| MODIFICA- OF EMIT CAD LIDOCAINE ASSAY (K832799) | Syva Co. | 1983-10-14 |
| EMIT QST LIDOCAINE ASSAY (K831354) | Syva Co. | 1983-05-27 |
Recalls involving this device
No recalls on record reference this clearance.