K932716 is an FDA 510(k) clearance for the EMIT(R) THC 50/100 NG ASSAY. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II - Special Controls, product code LDJ).
Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on October 1, 1993, 119 days after receiving the submission on June 4, 1993.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K932716 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 1993 |
| Decision Date | October 01, 1993 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |