ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET— 510(k) K072437
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K072437 for ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET, Substantially Equivalent on 2008-02-05. 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
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