Panels › Clinical Toxicology › Product code LAN · Class 2
Enzyme Immunoassay, N-Acetylprocainamide
Regulation 862.3320
0510(k)s in 12 months (21 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LAN
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 16, 2006 | K060738 | TDM N-ACETYLPROCAINAMIDE Roche Diagnostics Corp. | LAN |
| Oct 31, 2003 | K032564 | DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 Dade Behring, Inc. | LAN |
| Jun 18, 2001 | K011620 | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 Syva Co., Dade Behring, Inc. | LAN |
| Nov 16, 1998 | K983812 | NAPA EIA ASSAY Diagnostic Reagents, Inc. | LAN |
| Jun 11, 1997 | K971713 | N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM Bayer Corp. | LAN |
| Apr 24, 1996 | K955422 | AXSYM N-ACETYLPROCAINAMIDE Abbott Laboratories | LAN |
| Nov 22, 1993 | K934705 | OPUS NAPA Pb Diagnostic Systems, Inc. | LAN |
| Aug 24, 1992 | K922915 | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT Syva Co. | LAN |
| Oct 25, 1989 | K895571 | N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT Tudor Laboratories, Inc. | LAN |
| Sep 22, 1987 | K873349 | EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649 Em Diagnostic Systems, Inc. | LAN |
| Jun 8, 1987 | K871680 | MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR Roche Diagnostic Systems, Inc. | LAN |
| Feb 6, 1986 | K860140 | STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. American Dade | LAN |
| Sep 16, 1985 | K853547 | STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I American Dade | LAN |
| Jun 25, 1985 | K852319 | COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS Roche Diagnostic Systems, Inc. | LAN |
| Apr 5, 1985 | K851060 | EMIT QST N-ACETYLPROCAINAMIDE ASSAY Syva Co. | LAN |
| Dec 27, 1983 | K833378 | N-ACETYLPROCAINAMIDE ACA-ANALYTICAL E.I. Dupont DE Nemours & Co., Inc. | LAN |
| Aug 12, 1983 | K832098 | N-ACETYLPROCAINAMIDE ASSAY FOR COBAS Syva Co. | LAN |
| Jun 2, 1983 | K831399 | AMES TDA N-ACETYL-PROCAINAMIDE TEST Miles Laboratories, Inc. | LAN |
| Feb 18, 1983 | K830206 | TDX N-ACETYLPROCAINAMIDE Abbott Laboratories | LAN |
| Nov 29, 1982 | K823129 | ADVANCE EMIT-CAD N-ACETYLPROCAINAMIDE Syva Co. | LAN |
| Oct 10, 1978 | K781378 | EMIT N-ACETYLPROCAINAMIDE ASSAY Syva Co. | LAN |
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