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De Novo DEN150057
- Device
- Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
- Contact
- edie eads
- De Novo number
- DEN150057
- Product code
- PQO
- Regulation
- 862.1092
- Classification name
- anti-müllerian hormone test system
- Decision
- granted (DENG)
- Decision date
- 2016-12-19
- Date received
- 2015-12-09
- Classification advisory
- Clinical Chemistry
- Review advisory
- Clinical Chemistry
- Type
- Direct
Current FDA Classification#
- Product code
- PQO
- Device name
- Anti-Müllerian Hormone Test System
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation
- 862.1092
- Implant
- N
- Life sustain/support
- N