The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for The Emit 2000 Tacrolimus Calibrators.
| Device ID | K060371 |
| 510k Number | K060371 |
| Device Name: | THE EMIT 2000 TACROLIMUS CALIBRATORS |
| Classification | Calibrator, Secondary |
| Applicant | DADE BEHRING, INC. PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Uk-ting Lewis |
| Correspondent | Uk-ting Lewis DADE BEHRING, INC. PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-13 |
| Decision Date | 2006-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768001680 | K060371 | 000 |