510(k) K040887
K040887 is an FDA 510(k) premarket notification submitted by Brahms Aktiengesellschaft for the device "B-R-A-H-M-S PCT LIA". The FDA issued a decision of Substantially Equivalent on January 7, 2005. 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
- January 7, 2005
- Date Received
- April 5, 2004
- 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.