The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Cyclosporine Extended Range Calibrator (dc108a).
| Device ID | K061503 |
| 510k Number | K061503 |
| Device Name: | DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) |
| Classification | Calibrators, Drug Specific |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 MS 514 Newark, DE 19714 -6101 |
| Contact | Andrea M Tasker |
| Correspondent | Andrea M Tasker DADE BEHRING, INC. P.O. BOX 6101 MS 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 | 2006-06-01 |
| Decision Date | 2006-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768018213 | K061503 | 000 |