K163220 is an FDA 510(k) clearance for the Atellica CH Phencyclidine (Pcp). This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on April 6, 2017, 141 days after receiving the submission on November 16, 2016.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K163220 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2016 |
| Decision Date | April 06, 2017 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |