K840194 is an FDA 510(k) clearance for the EMIT ST SERUM BARBITURATE ASSAY. This device is classified as a Enzyme Immunoassay, Barbiturate (Class II - Special Controls, product code DIS).
Submitted by Syva Co. (Walker, US). The FDA issued a Cleared decision on March 19, 1984, 61 days after receiving the submission on January 18, 1984.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3150.
| 510(k) Number | K840194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 1984 |
| Decision Date | March 19, 1984 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DIS — Enzyme Immunoassay, Barbiturate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3150 |