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 Phencyclidine Assay, Model Osr9j229.
| Device ID | K011161 |
| 510k Number | K011161 |
| Device Name: | MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 |
| Classification | Enzyme Immunoassay, Phencyclidine |
| 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 | LCM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-16 |
| Decision Date | 2001-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768023422 | K011161 | 000 |