The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Emit 2000 Cyclosporine Specific Assay.
| Device ID | K053061 |
| 510k Number | K053061 |
| Device Name: | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY |
| Classification | Cyclosporine |
| 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 | MKW |
| CFR Regulation Number | 862.1235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-31 |
| Decision Date | 2006-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768001451 | K053061 | 000 |