K843534 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 (Glendale, US). The FDA issued a Cleared decision on October 30, 1984, 53 days after receiving the submission on September 7, 1984.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K843534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 1984 |
| Decision Date | October 30, 1984 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LAT — Radioimmunoassay, Cannabinoid(s) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |