510(k) K070310
K070310 is an FDA 510(k) premarket notification submitted by Brahms Aktiengesellschaft for the device "B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on March 31, 2008. The device falls under product code NTM (Antigen, Inflammatory Response Marker, Sepsis), a Class II device regulated under 21 CFR 866.3210. Brahms Aktiengesellschaft has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2008
- Date Received
- February 1, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Inflammatory Response Marker, Sepsis
- Device Class
- Class II
- Regulation Number
- 866.3210
- Review Panel
- MI
- Submission Type
An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma.