The following data is part of a premarket notification filed by Syva Co. with the FDA for Syva Emit Ii Plus Cannabinoid Assay, Models 9n029ul/9n129ul.
| Device ID | K993984 |
| 510k Number | K993984 |
| Device Name: | SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL |
| Classification | Enzyme Immunoassay, Cannabinoids |
| 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 | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-24 |
| Decision Date | 2000-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596099 | K993984 | 000 |
| 00630414568829 | K993984 | 000 |
| 00842768014420 | K993984 | 000 |
| 00842768002199 | K993984 | 000 |
| 00842768002182 | K993984 | 000 |