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 |