The following data is part of a premarket notification filed by Immunexpress, Inc. with the FDA for Septicyte Lab.
| Device ID | K163260 |
| 510k Number | K163260 |
| Device Name: | SeptiCyte LAB |
| Classification | Rt-qpcr Assay For Mrna Transcript Immune Biomarkers |
| Applicant | IMMUNEXPRESS, INC. 425 PONTIUS AVE. NORTH Seattle, WA 98109 |
| Contact | Victoria Rothwell |
| Correspondent | Victoria Rothwell IMMUNEXPRESS, INC. 425 PONTIUS AVE. NORTH Seattle, WA 98109 |
| Product Code | PRE |
| CFR Regulation Number | 866.3215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-21 |
| Decision Date | 2017-02-17 |
| Summary: | summary |