K232095
- 510(k) number
- K232095
- Device name
- SeptiCyte RAPID
- Applicant
- Immunexpress, Inc. WA · US
- Product code
- PRE — Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
- Decision date
- 2023-12-15
- Date received
- 2023-07-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K232095
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.