510(k) K071597
- Device
- DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
- Applicant
- DADE BEHRING, INC.
- 510(k) number
- K071597
- Product code
- LOJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-06-04
- Date received
- 2007-06-12
- Regulation
- 866.6010
- Classification name
- Kit, Test,alpha-fetoprotein For Testicular Cancer
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAMELA A JURGA
- Address
- P.O. Box 6101 Bldg. 500;M.S.514 Newark DE US 19714 19714
FDA Registration Numbers#
- 2246703
- 8031673
- 2032839
- 3005529799
- 2517506
- 9612316
- 2432235
- 3007111389
- 9610126
- 3006198300
- 1036362
- 3002806944
- 1219913
- 1319681
Source Documents#
Other 510(k) Records For Product Code LOJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220176 | Elecsys AFP | Roche Diagnostics | 2022-09-15 |
| K213626 | VITROS AFP | Ortho Clinical Diagnostics | 2022-06-15 |
| K090236 | DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 | Siemens Healthcare Diagnostics | 2009-04-27 |
| K081709 | OLYMPUS AFP - ALPHA-FETOPROTEIN | Olympus Life Science Research Europa GmbH (Europa) | 2009-03-16 |
| K080017 | VIDAS AFP ASSAY | bioMerieux, Inc. | 2008-09-26 |
| K023894 | ST AIA-PACK AFP ENZYME IMMUNOASSAY | Tosoh Medics, Inc. | 2002-12-17 |
| K020807 | AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-10-01 |
| K020806 | ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY | Bayer Corp. | 2002-03-27 |
| K990138 | DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 | Diagnostic Systems Laboratories, Inc. | 1999-06-21 |
| K983031 | VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY | Ortho-Clinical Diagnostics, Inc. | 1998-12-18 |
| K983263 | IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 | Diagnostic Products Corp. | 1998-12-07 |
| K981282 | ELECSYS AFP | Roche Diagnostics GmbH | 1998-05-01 |
| K981354 | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 | Beckman Instruments, Inc. | 1998-05-01 |
| K973351 | ELECSYS AFP | Boehringer Mannheim Corp. | 1997-11-21 |
| K972462 | AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | 1997-09-22 |
Legacy Summary#
summary
FDA Review#
Decision Summary