Invitae Common Hereditary Cancers Panel
FDA 510(k) clearance DEN210011 · decided 2023-09-29
Clearance details
- K-number
- DEN210011
- Device name
- Invitae Common Hereditary Cancers Panel
- Applicant
- Invitae Corporation
- Decision
- Unknown
- Date received
- 2021-03-29
- Decision date
- 2023-09-29
- Days to decision
- 914 days
- Clearance type
- Direct
- Product code
- QVU
- Device class
- 2
- Regulation number
- 866.6095
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.