510(k) DEN150009
DEN150009 is an FDA 510(k) premarket notification submitted by Brahms GmbH for the device "B.R.A.H.M.S PCT sensitive KRYPTOR". The FDA issued a decision of De Novo Granted on February 20, 2016. The device falls under product code PMT (Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens), a Class II device regulated under 21 CFR 866.3215. Brahms GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 20, 2016
- Date Received
- March 4, 2015
- Clearance Type
- Direct
- 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.