510(k) K111452
K111452 is an FDA 510(k) premarket notification submitted by Critical Care Diagnostics, Inc. (Dba Critical Diag for the device "PRESAGE ST2 ASSAY". The FDA issued a decision of Substantially Equivalent on December 9, 2011. The device falls under product code OYG (St2 Assay), a Class II device regulated under 21 CFR 862.1117.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2011
- Date Received
- May 25, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- St2 Assay
- Device Class
- Class II
- Regulation Number
- 862.1117
- Review Panel
- CH
- Submission Type
Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.