LAN — Enzyme Immunoassay, N-Acetylprocainamide Class II
FDA product code LAN covers "Enzyme Immunoassay, N-Acetylprocainamide", a Class II medical device regulated under 21 CFR 862.3320. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LAN
- Device Class
- Class II
- Regulation Number
- 862.3320
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K060738 | roche diagnostics | TDM N-ACETYLPROCAINAMIDE | August 16, 2006 |
| K032564 | dade behring | DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 | October 31, 2003 |
| K011620 | syva co., dade behring | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 | June 18, 2001 |
| K983812 | diagnostic reagents | NAPA EIA ASSAY | November 16, 1998 |
| K971713 | bayer | N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | June 11, 1997 |
| K955422 | abbott laboratories | AXSYM N-ACETYLPROCAINAMIDE | April 24, 1996 |
| K934705 | pb diagnostic systems | OPUS NAPA | November 22, 1993 |
| K922915 | syva | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT | August 24, 1992 |
| K895571 | tudor laboratories | N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT | October 25, 1989 |
| K873349 | em diagnostic systems | EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649 | September 22, 1987 |
| K871680 | roche diagnostic systems | MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR | June 8, 1987 |
| K860140 | american dade | STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. | February 6, 1986 |
| K853547 | american dade | STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I | September 16, 1985 |
| K852319 | roche diagnostic systems | COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS | June 25, 1985 |
| K851060 | syva | EMIT QST N-ACETYLPROCAINAMIDE ASSAY | April 5, 1985 |
| K833378 | e.i. dupont de nemours and co | N-ACETYLPROCAINAMIDE ACA-ANALYTICAL | December 27, 1983 |
| K832098 | syva | N-ACETYLPROCAINAMIDE ASSAY FOR COBAS | August 12, 1983 |
| K831399 | miles laboratories | AMES TDA N-ACETYL-PROCAINAMIDE TEST | June 2, 1983 |
| K830206 | abbott laboratories | TDX N-ACETYLPROCAINAMIDE | February 18, 1983 |
| K823129 | syva | ADVANCE EMIT-CAD N-ACETYLPROCAINAMIDE | November 29, 1982 |