The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Csae Cyclosporine Extended Range Calibrator, Model Dc108.
| Device ID | K053108 |
| 510k Number | K053108 |
| Device Name: | DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 |
| Classification | Calibrators, Drug Specific |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101, M/S 514 Newark, DE 19702 |
| Contact | Yuk-ting Lewis |
| Correspondent | Yuk-ting Lewis DADE BEHRING, INC. P.O. BOX 6101, M/S 514 Newark, DE 19702 |
| Product Code | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-04 |
| Decision Date | 2006-02-16 |
| Summary: | summary |