K012257 is an FDA 510(k) clearance for the EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by Syva Co. (Cupertino, US). The FDA issued a Cleared decision on August 3, 2001, 16 days after receiving the submission on July 18, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K012257 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2001 |
| Decision Date | August 03, 2001 |
| Days to Decision | 16 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DKZ — Enzyme Immunoassay, Amphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |