The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Emit Ii Plus Ecstasy Assay.
| Device ID | K043028 |
| 510k Number | K043028 |
| Device Name: | EMIT II PLUS ECSTASY ASSAY |
| Classification | Enzyme Immunoassay, Amphetamine |
| 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 | DKZ |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DLJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-03 |
| Decision Date | 2005-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414595955 | K043028 | 000 |
| 00630414569857 | K043028 | 000 |
| 00842768023460 | K043028 | 000 |
| 00842768021947 | K043028 | 000 |
| 00842768002229 | K043028 | 000 |