K791649 is an FDA 510(k) clearance for the TETRAHYDROCANNALBINOL DIRECT BLOOD 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 October 11, 1979, 48 days after receiving the submission on August 24, 1979.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K791649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 1979 |
| Decision Date | October 11, 1979 |
| Days to Decision | 48 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 |