Skip to contentDe Novo DEN230068
- Device
- 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190
- Contact
- michelle larsen
- De Novo number
- DEN230068
- Product code
- JOJ
- Regulation
- 880.2800
- Classification name
- indicator, physical/chemical sterilization process
- Decision
- granted (DENG)
- Decision date
- 2024-05-21
- Date received
- 2023-09-29
- Classification advisory
- General Hospital
- Review advisory
- General Hospital
- Type
- Direct
Current FDA Classification#
- Product code
- JOJ
- Device name
- Indicator, Physical/Chemical Sterilization Process
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.2800
- Implant
- N
- Life sustain/support
- N