The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista B2mic Flex Reagent Cartridge, Protein 1 Calibrator, Control Medium, Control High.
| Device ID | K063272 |
| 510k Number | K063272 |
| Device Name: | DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| 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 | JZG |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-30 |
| Decision Date | 2007-01-26 |
| Summary: | summary |