Product code LAN
- Device name
- Enzyme Immunoassay, N-Acetylprocainamide
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3320
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K060738 | TDM N-ACETYLPROCAINAMIDE | Roche Diagnostics Corp. | 2006-08-16 |
| K032564 | DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 | Dade Behring, Inc. | 2003-10-31 |
| K011620 | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 | Syva Co., Dade Behring, Inc. | 2001-06-18 |
| K983812 | NAPA EIA ASSAY | Diagnostic Reagents, Inc. | 1998-11-16 |
| K971713 | N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | 1997-06-11 |
| K955422 | AXSYM N-ACETYLPROCAINAMIDE | Abbott Laboratories | 1996-04-24 |
| K934705 | OPUS NAPA | Pb Diagnostic Systems, Inc. | 1993-11-22 |
| K922915 | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT | Syva Co. | 1992-08-24 |
| K895571 | N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT | Tudor Laboratories, Inc. | 1989-10-25 |
| K873349 | EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649 | Em Diagnostic Systems, Inc. | 1987-09-22 |
| K871680 | MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR | Roche Diagnostic Systems, Inc. | 1987-06-08 |
| K860140 | STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. | American Dade | 1986-02-06 |
| K853547 | STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I | American Dade | 1985-09-16 |
| K852319 | COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS | Roche Diagnostic Systems, Inc. | 1985-06-25 |
| K851060 | EMIT QST N-ACETYLPROCAINAMIDE ASSAY | Syva Co. | 1985-04-05 |
| K833378 | N-ACETYLPROCAINAMIDE ACA-ANALYTICAL | E.I. Dupont DE Nemours & Co., Inc. | 1983-12-27 |
| K832098 | N-ACETYLPROCAINAMIDE ASSAY FOR COBAS | Syva Co. | 1983-08-12 |
| K831399 | AMES TDA N-ACETYL-PROCAINAMIDE TEST | Miles Laboratories, Inc. | 1983-06-02 |
| K830206 | TDX N-ACETYLPROCAINAMIDE | Abbott Laboratories | 1983-02-18 |
| K823129 | ADVANCE EMIT-CAD N-ACETYLPROCAINAMIDE | Syva Co. | 1982-11-29 |
| K781378 | EMIT N-ACETYLPROCAINAMIDE ASSAY | Syva Co. | 1978-10-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336147870 | ONLINE TDM N-acetylprocainamide | Roche Diagnostics GmbH | 2020-03-05 |
| 00630414220659 | Atellica CH NAPA | Siemens Healthcare Diagnostics Inc. | 2018-10-08 |
| 00842768001017 | Syva® Emit® 2000 N-Acetylprocainamide Calibrators | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768005299 | Dimension® Flex® reagent cartridge NAPA | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768015342 | Dimension Vista® Flex® reagent cartridge NAPA | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768017421 | Syva® Emit® 2000 N-Acetylprocainamide Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768023279 | Emit® 2000 N-Acetylprocainamide Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04015630998968 | Nacetylprocainamide | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630915750 | NAcetylProcainamide | Roche Diagnostics GmbH | 2016-09-20 |