The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Emit 2000 Tacrolimus Assay And Sample Pretreatment Reagent.
| Device ID | K060385 |
| 510k Number | K060385 |
| Device Name: | EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT |
| Classification | Enzyme Immunoassay, Tracrolimus |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714 |
| Contact | Yuk-ting Lewis |
| Correspondent | Yuk-ting Lewis DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714 |
| Product Code | MLM |
| CFR Regulation Number | 862.1678 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-14 |
| Decision Date | 2006-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414238340 | K060385 | 000 |
| 00842768001666 | K060385 | 000 |