Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5— 510(k) DEN150057
UnknownRoche Diagnostics
FDA 510(k) clearance DEN150057 for Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5, Unknown on 2016-12-19. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code PQO
- Device class
- Class 2
- Regulation
- 21 CFR 862.1092
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Indianapolis, IN, US
Recent devices under product code PQO
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