Elecsys proBNP II, Elecsys proBNP II STAT— 510(k) K210546
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K210546 for Elecsys proBNP II, Elecsys proBNP II STAT, Substantially Equivalent on 2022-03-31. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code NBC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1117
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code NBC
view allMore clearances from Roche Diagnostics
view allData sourced from openFDA. This site is unofficial and independent of the FDA.