Proov Test— 510(k) K191462
Substantially EquivalentMfb Fertility, Inc.
FDA 510(k) clearance K191462 for Proov Test, Substantially Equivalent on 2020-02-27. Applicant: Mfb Fertility, Inc.. Device class: 1.
Clearance details
- Applicant
- Mfb Fertility, Inc.
- Product code
- Code QKE
- Device class
- Class 1
- Regulation
- 21 CFR 862.1620
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Erie, CO, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.