K935352 is an FDA 510(k) clearance for the EMIT(R) IIC AMPHETAMINE ASSAY. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on February 22, 1995, 474 days after receiving the submission on November 5, 1993.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K935352 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 1993 |
| Decision Date | February 22, 1995 |
| Days to Decision | 474 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DKZ — Enzyme Immunoassay, Amphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |