510(k) K162297
K162297 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set". The FDA issued a decision of Substantially Equivalent on April 18, 2017. The device falls under product code PTF (Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission), a Class II device regulated under 21 CFR 866.3215. Diazyme Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 2017
- Date Received
- August 16, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
- Device Class
- Class II
- Regulation Number
- 866.3215
- Review Panel
- MI
- Submission Type
Assay to measure procalcitonin to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock