K994005 is an FDA 510(k) clearance for the SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL. This device is classified as a Enzyme Immunoassay, Methadone (Class II - Special Controls, product code DJR).
Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 20, 2000, 57 days after receiving the submission on November 24, 1999.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3620.
| 510(k) Number | K994005 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 1999 |
| Decision Date | January 20, 2000 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DJR — Enzyme Immunoassay, Methadone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3620 |