DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
FDA 510(k) clearance K071597 · decided 2008-06-04
Clearance details
- K-number
- K071597
- Device name
- DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-06-12
- Decision date
- 2008-06-04
- Days to decision
- 358 days
- Clearance type
- Traditional
- Product code
- LOJ
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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 |
|---|---|---|
| Elecsys AFP (K220176) | Roche Diagnostics | 2022-09-15 |
| VITROS AFP (K213626) | Ortho Clinical Diagnostics | 2022-06-15 |
| DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 (K090236) | Siemens Healthcare Diagnostics | 2009-04-27 |
| OLYMPUS AFP - ALPHA-FETOPROTEIN (K081709) | Olympus Life Science Research Europa GmbH (Europa) | 2009-03-16 |
| VIDAS AFP ASSAY (K080017) | bioMerieux, Inc. | 2008-09-26 |
| ST AIA-PACK AFP ENZYME IMMUNOASSAY (K023894) | Tosoh Medics, Inc. | 2002-12-17 |
| AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020807) | Bayer Diagnostics Corp. | 2002-10-01 |
| ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY (K020806) | Bayer Corp. | 2002-03-27 |
| DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 (K990138) | Diagnostic Systems Laboratories, Inc. | 1999-06-21 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY (K983031) | Ortho-Clinical Diagnostics, Inc. | 1998-12-18 |
| IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 (K983263) | Diagnostic Products Corp. | 1998-12-07 |
| ELECSYS AFP (K981282) | Roche Diagnostics GmbH | 1998-05-01 |
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 |