510(k) K210546
K210546 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys proBNP II, Elecsys proBNP II STAT". The FDA issued a decision of Substantially Equivalent on March 31, 2022. The device falls under product code NBC (Test, Natriuretic Peptide), a Class II device regulated under 21 CFR 862.1117. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2022
- Date Received
- February 25, 2021
- 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