K993984 is an FDA 510(k) clearance for the SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL. 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 January 18, 2000, 55 days after receiving the submission on November 24, 1999.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K993984 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 1999 |
| Decision Date | January 18, 2000 |
| Days to Decision | 55 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 |