510(k) K220265
K220265 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "ADVIA Centaur® NT-proBNPII (PBNPII)". The FDA issued a decision of Substantially Equivalent on September 24, 2023. The device falls under product code NBC (Test, Natriuretic Peptide), a Class II device regulated under 21 CFR 862.1117. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 2023
- Date Received
- January 31, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Natriuretic Peptide
- Device Class
- Class II
- Regulation Number
- 862.1117
- Review Panel
- CH
- Submission Type