DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
FDA 510(k) clearance K032564 · decided 2003-10-31
Clearance details
- K-number
- K032564
- Device name
- DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-20
- Decision date
- 2003-10-31
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- LAN
- Device class
- 2
- Regulation number
- 862.3320
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- P.O. Box 6101, Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TDM N-ACETYLPROCAINAMIDE (K060738) | Roche Diagnostics Corp. | 2006-08-16 |
| EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 (K011620) | Syva Co., Dade Behring, Inc. | 2001-06-18 |
| NAPA EIA ASSAY (K983812) | Diagnostic Reagents, Inc. | 1998-11-16 |
| N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K971713) | Bayer Corp. | 1997-06-11 |
| AXSYM N-ACETYLPROCAINAMIDE (K955422) | Abbott Laboratories | 1996-04-24 |
| OPUS NAPA (K934705) | Pb Diagnostic Systems, Inc. | 1993-11-22 |
| EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT (K922915) | Syva Co. | 1992-08-24 |
| N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT (K895571) | Tudor Laboratories, Inc. | 1989-10-25 |
| EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649 (K873349) | Em Diagnostic Systems, Inc. | 1987-09-22 |
| MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR (K871680) | Roche Diagnostic Systems, Inc. | 1987-06-08 |
| STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. (K860140) | American Dade | 1986-02-06 |
| STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I (K853547) | American Dade | 1985-09-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003) | Dade Behring, Inc. | 2002-07-24 |
| COBAS INTEGRA CYCLOSPORINE (P920031/S002) | Dade Behring, Inc. | 2002-02-26 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001) | Dade Behring, Inc. | 2000-08-11 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031) | Dade Behring, Inc. | 1996-10-02 |