The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit Iic Cannabinoid Assay.
| Device ID | K940158 |
| 510k Number | K940158 |
| Device Name: | EMIT IIC CANNABINOID ASSAY |
| 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 | 1994-01-12 |
| Decision Date | 1995-02-22 |