DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE
FDA 510(k) clearance K062024 · decided 2006-07-28
Clearance details
- K-number
- K062024
- Device name
- DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-18
- Decision date
- 2006-07-28
- Days to decision
- 10 days
- Clearance type
- Special
- Product code
- LFM
- Device class
- 2
- Regulation number
- 862.3300
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- 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 |
|---|---|---|
| RANDOX DIGITOXIN (K012112) | Randox Laboratories, Ltd. | 2002-01-11 |
| DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 (K990251) | Dade Behring, Inc. | 1999-03-31 |
| ACS DIGITOXIN (K970546) | Chiron Diagnostics Corp. | 1997-07-14 |
| ABBOTT AXSYM DIGITOXIN (MODIFY) (K963158) | Abbott Laboratories | 1996-09-10 |
| AXSYM DIGITOXIN (K954420) | Abbott Laboratories | 1995-12-29 |
| DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS (K951631) | Bayer Corp. | 1995-06-09 |
| IMMULITE DIGITOXIN (K943235) | Diagnostic Products Corp. | 1994-10-27 |
| KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) (K942610) | Eastman Kodak Company | 1994-10-20 |
| EMIT 2000 DIGOXIN ASSAY/CALIBRATORS (K942619) | Syva Co. | 1994-09-20 |
| DIGITOXIN FPIA REAGENT SET (K915465) | Sigma Diagnostics, Inc. | 1992-01-27 |
| INNOFLUOR(TM) DIGITOXIN REAGENT SET (K913187) | Intl. Bioclinical, Inc. | 1991-09-23 |
| DIGITOXIN (FPIA) KIT (K913240) | Tudor Laboratories, Inc. | 1991-09-06 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The recall (Z-0408-2013) | Siemens Healthcare Diagnostics, Inc. | 2012-11-20 |
| Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012 This method is an in recall (Z-1739-2011) | Siemens Healthcare Diagnostics, Inc. | 2011-03-21 |
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 |