510(k) K160729
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2016
- Date Received
- March 16, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
- Device Class
- Class II
- Regulation Number
- 866.3215
- Review Panel
- MI
- Submission Type
An assay used to determine the level of procalcitonin (PCT) in human serum and plasma as an aid in assessing the mortality for patients diagnosed with severe sepsis or septic shock.