K011161 is an FDA 510(k) clearance for the MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on May 15, 2001, 29 days after receiving the submission on April 16, 2001.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K011161 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2001 |
| Decision Date | May 15, 2001 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |