The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Stfr Flex Reagent Cartridge And Protein 1 Calibrator And Control L, M And H.
| Device ID | K063663 |
| 510k Number | K063663 |
| Device Name: | DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H |
| Classification | Transferrin, Antigen, Antiserum, Control |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Contact | Kathleen Dray-lyons |
| Correspondent | Kathleen Dray-lyons DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Product Code | DDG |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-08 |
| Decision Date | 2007-03-21 |
| Summary: | summary |