The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Cyclosporine Calibrator.
| Device ID | K011112 |
| 510k Number | K011112 |
| Device Name: | CYCLOSPORINE CALIBRATOR |
| Classification | Calibrators, Drug Specific |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 BUILDING 500 GLASGOW BUSINESS COMMUNITY Newark,, DE 19714 |
| Contact | Lorraine H Piestrak |
| Correspondent | Lorraine H Piestrak DADE BEHRING, INC. P.O. BOX 6101 BUILDING 500 GLASGOW BUSINESS COMMUNITY Newark,, DE 19714 |
| Product Code | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-11 |
| Decision Date | 2001-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005213 | K011112 | 000 |