K821965 is an FDA 510(k) clearance for the ORAL THC-CANNABINOIDS DIRECT RIA KIT. This device is classified as a Radioimmunoassay, Cannabinoid(s) (Class II - Special Controls, product code LAT).
Submitted by Immunalysis Corporation (Mchenry, US). The FDA issued a Cleared decision on July 20, 1982, 18 days after receiving the submission on July 2, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K821965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 1982 |
| Decision Date | July 20, 1982 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LAT — Radioimmunoassay, Cannabinoid(s) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |