FDA 510(k) Applications for Medical Device Product Code "LAN"
(Enzyme Immunoassay, N-Acetylprocainamide)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K955422 | ABBOTT LABORATORIES | AXSYM N-ACETYLPROCAINAMIDE | 04/24/1996 |
| K971713 | BAYER CORP. | N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | 06/11/1997 |
| K032564 | DADE BEHRING, INC. | DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 | 10/31/2003 |
| K983812 | DIAGNOSTIC REAGENTS, INC. | NAPA EIA ASSAY | 11/16/1998 |
| K060738 | ROCHE DIAGNOSTICS CORP. | TDM N-ACETYLPROCAINAMIDE | 08/16/2006 |
| K011620 | SYVA CO., DADE BEHRING, INC. | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 | 06/18/2001 |
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