The following data is part of a premarket notification filed by Syva Co., Dade Behring, Inc. with the FDA for Emit Ii Plus Opiate Assay, Model Osr9b229.
| Device ID | K011289 |
| 510k Number | K011289 |
| Device Name: | EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | SYVA CO., DADE BEHRING, INC. P.O. BOX 49013 3403 YERBA BUENA ROAD San Jose, CA 95135 |
| Contact | Susan Collins |
| Correspondent | Susan Collins SYVA CO., DADE BEHRING, INC. P.O. BOX 49013 3403 YERBA BUENA ROAD San Jose, CA 95135 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-27 |
| Decision Date | 2001-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768023354 | K011289 | 000 |