The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista (r) Afp Flex(r) Reagent Cartridge, Model K6454, Dimension Vista (r) Loci 5 Calibrator, Model Kc600.
| Device ID | K071597 |
| 510k Number | K071597 |
| Device Name: | DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 |
| Classification | Kit, Test,alpha-fetoprotein For Testicular Cancer |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101 |
| Contact | Pamela A Jurga |
| Correspondent | Pamela A Jurga DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101 |
| Product Code | LOJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-12 |
| Decision Date | 2008-06-04 |
| Summary: | summary |