The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Tacr Flex Reagent Cartridge, Model Df107.
| Device ID | K060502 |
| 510k Number | K060502 |
| Device Name: | DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 |
| Classification | Enzyme Immunoassay, Tracrolimus |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 M/S 514 Newark, DE 19714 -6101 |
| Contact | Yuk-ting Lewis |
| Correspondent | Yuk-ting Lewis DADE BEHRING, INC. P.O. BOX 6101 M/S 514 Newark, DE 19714 -6101 |
| Product Code | MLM |
| CFR Regulation Number | 862.1678 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-24 |
| Decision Date | 2006-05-18 |
| Summary: | summary |