The following data is part of a premarket notification filed by Syva Co., Dade Behring, Inc. with the FDA for Modification To The Emit Ii Plus Propoxyphene Assay, Model Osr9g229.
| Device ID | K011163 |
| 510k Number | K011163 |
| Device Name: | MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 |
| Classification | Enzyme Immunoassay, Propoxyphene |
| Applicant | SYVA CO., DADE BEHRING, INC. 3403 YERBA BUENA RD. San Jose, CA 95135 |
| Contact | Susan Collins |
| Correspondent | Susan Collins SYVA CO., DADE BEHRING, INC. 3403 YERBA BUENA RD. San Jose, CA 95135 |
| Product Code | JXN |
| CFR Regulation Number | 862.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-16 |
| Decision Date | 2001-05-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768023408 | K011163 | 000 |