The following data is part of a premarket notification filed by Syva Co. with the FDA for Syva Emit Ii Plus Methadone Assay, Models 9e029ul/9e129ul.
| Device ID | K994005 |
| 510k Number | K994005 |
| Device Name: | SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL |
| Classification | Enzyme Immunoassay, Methadone |
| 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 | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-24 |
| Decision Date | 2000-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414595917 | K994005 | 000 |
| 00630414568782 | K994005 | 000 |
| 00842768014369 | K994005 | 000 |
| 00842768000157 | K994005 | 000 |
| 00842768000133 | K994005 | 000 |