510(k) K011620
- Device
- EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
- Applicant
- SYVA CO., DADE BEHRING, INC.
- 510(k) number
- K011620
- Product code
- LAN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-06-18
- Date received
- 2001-05-25
- Regulation
- 862.3320
- Classification name
- Enzyme Immunoassay, N-acetylprocainamide
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CYNTHIA ARREDONDO
- Address
- 3403 Yerba Buena Rd. San Jose CA US 95135 95135
FDA Registration Numbers#
- 9610126
- 3006198300
- 3003795116
- 3010825766
- 2517506
- 2432235
- 9610529
Source Documents#
Other 510(k) Records For Product Code LAN #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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