The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Atellica Ch Phencyclidine (pcp).
| Device ID | K163220 |
| 510k Number | K163220 |
| Device Name: | Atellica CH Phencyclidine (Pcp) |
| Classification | Enzyme Immunoassay, Phencyclidine |
| Applicant | Siemens Healthcare Diagnostics, Inc. 500 GBC Drive, PO Box 6101 MS 514 Newark, DE 19711 |
| Contact | Laura J. Duggan |
| Correspondent | Laura J. Duggan Siemens Healthcare Diagnostics, Inc. 500 GBC Drive, PO Box 6101 MS 514 Newark, DE 19711 |
| Product Code | LCM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-16 |
| Decision Date | 2017-04-06 |
| Summary: | summary |