510(k) DEN210011
- Device
- Invitae Common Hereditary Cancers Panel
- Applicant
- Invitae Corporation
- 510(k) number
- DEN210011
- Product code
- QVU
- Decision
- Unknown (DENG)
- Decision date
- 2023-09-29
- Date received
- 2021-03-29
- Regulation
- 866.6095
- Classification name
- High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Elaine Cull
- Address
- 1400 16th St. San Francisco CA US 94103 94103
Source Documents
510(k) summary PDF not indicated by FDA