MUTYH-Associated Polyposis (MAP)
FDA 510(k) clearance K182784 · decided 2019-01-18
Clearance details
- K-number
- K182784
- Device name
- MUTYH-Associated Polyposis (MAP)
- Applicant
- 23AndMe, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-10-01
- Decision date
- 2019-01-18
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- QAZ
- Device class
- 2
- Regulation number
- 866.6090
- Medical specialty
- Medical Genetics
- Advisory committee
- Medical Genetics
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.