OYG — St2 Assay Class II
FDA product code OYG covers "St2 Assay", a Class II medical device regulated under 21 CFR 862.1117. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OYG
- Device Class
- Class II
- Regulation Number
- 862.1117
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K111452 | critical care diagnostics, inc. (dba critical diag | PRESAGE ST2 ASSAY | December 9, 2011 |