Paige Prostate
FDA 510(k) clearance DEN200080 · decided 2021-09-21
Clearance details
- K-number
- DEN200080
- Device name
- Paige Prostate
- Applicant
- Paige.Ai
- Decision
- Unknown
- Date received
- 2020-12-31
- Decision date
- 2021-09-21
- Days to decision
- 264 days
- Clearance type
- Direct
- Product code
- QPN
- Device class
- 2
- Regulation number
- 864.3750
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.