The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Oral Thc-cannabinoids Direct Ria Kit.
| Device ID | K843534 |
| 510k Number | K843534 |
| Device Name: | ORAL THC-CANNABINOIDS DIRECT RIA KIT |
| Classification | Radioimmunoassay, Cannabinoid(s) |
| Applicant | Immunalysis Corporation 1707 GARDENA AVE. Glendale, CA 91204 |
| Contact | James R Soares |
| Correspondent | James R Soares Immunalysis Corporation 1707 GARDENA AVE. Glendale, CA 91204 |
| Product Code | LAT |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-07 |
| Decision Date | 1984-10-30 |