The following data is part of a premarket notification filed by Syva Co. with the FDA for Syva Emit Ii Plus Amphetamine/methamphetamine Assay 9c029ul/9c129ul.
| Device ID | K993982 |
| 510k Number | K993982 |
| Device Name: | SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL |
| Classification | Gas Chromatography, Methamphetamine |
| Applicant | SYVA CO. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Contact | Paul L Rogers |
| Correspondent | Paul L Rogers SYVA CO. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Product Code | LAF |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-24 |
| Decision Date | 2000-01-27 |
| Summary: | summary |