The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Tacr Calibrator, Model Dc107.
| Device ID | K060503 |
| 510k Number | K060503 |
| Device Name: | DIMENSION TACR CALIBRATOR, MODEL DC107 |
| Classification | Calibrators, Drug Specific |
| 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 | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| 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 |