K926068 is an FDA 510(k) clearance for the EMIT(R) II BARBITURATE ASSAY. This device is classified as a Enzyme Immunoassay, Barbiturate (Class II - Special Controls, product code DIS).
Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 12, 1993, 42 days after receiving the submission on December 1, 1992.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3150.
| 510(k) Number | K926068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1992 |
| Decision Date | January 12, 1993 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DIS — Enzyme Immunoassay, Barbiturate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3150 |