The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit Ii Plus Monoclonal Amphetamine/methamphetamine Assay Model Osr9c229.
| Device ID | K012257 |
| 510k Number | K012257 |
| Device Name: | EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | SYVA CO. 20400 MARIANI AVE. Cupertino, CA 95014 |
| Contact | Susan L Collins |
| Correspondent | Susan L Collins SYVA CO. 20400 MARIANI AVE. Cupertino, CA 95014 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-18 |
| Decision Date | 2001-08-03 |
| Summary: | summary |