Clearance Summary
Proov Test received FDA 510(k) clearance under submission number K191462, sponsored by Mfb Fertility, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2020-02-27.
- Submission: K191462
- Applicant / Sponsor: Mfb Fertility, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1620
- Decision date: 2020-02-27
Classification & Regulation
This clearance is catalogued under FDA product code QKE and 21 CFR 862.1620, within the Clinical Chemistry review panel as a Class I device.