Proov Test
FDA 510(k) clearance K191462 · decided 2020-02-27
Clearance details
- K-number
- K191462
- Device name
- Proov Test
- Applicant
- Mfb Fertility, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-06-03
- Decision date
- 2020-02-27
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- QKE
- Device class
- 1
- Regulation number
- 862.1620
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Erie, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.