The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Thc-cannabinoids Direct Urine Ria Kit.
| Device ID | K820903 |
| 510k Number | K820903 |
| Device Name: | THC-CANNABINOIDS DIRECT URINE RIA KIT |
| Classification | Radioimmunoassay, Cannabinoid(s) |
| Applicant | Immunalysis Corporation 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LAT |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-31 |
| Decision Date | 1982-05-05 |