510(k) K203748
K203748 is an FDA 510(k) premarket notification submitted by Immunexpress, Inc. for the device "SeptiCyte RAPID". The FDA issued a decision of Substantially Equivalent on November 29, 2021. The device falls under product code PRE (Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers), a Class II device regulated under 21 CFR 866.3215. Immunexpress, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 2021
- Date Received
- December 23, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
- Device Class
- Class II
- Regulation Number
- 866.3215
- Review Panel
- MI
- Submission Type
A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood.