Clearance Summary
PRESAGE ST2 ASSAY received FDA 510(k) clearance under submission number K111452, sponsored by Critical Care Diagnostics, Inc. (Dba Critical Diag. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2011-12-09.
- Submission: K111452
- Applicant / Sponsor: Critical Care Diagnostics, Inc. (Dba Critical Diag
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1117
- Decision date: 2011-12-09
Classification & Regulation
This clearance is catalogued under FDA product code OYG and 21 CFR 862.1117, within the Clinical Chemistry review panel as a Class II device.