510(k) K191462
K191462 is an FDA 510(k) premarket notification submitted by Mfb Fertility, Inc. for the device "Proov Test". The FDA issued a decision of Substantially Equivalent on Feb 27, 2020. The device falls under product code QKE (Immunoassay, Pregnanediol Glucuronide, Over The Counter), a Class I device regulated under 21 CFR 862.1620.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 27, 2020
- Date Received
- Jun 3, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoassay, Pregnanediol Glucuronide, Over The Counter
- Device Class
- Class I
- Regulation Number
- 862.1620
- Review Panel
- TX
- Submission Type
- 510(k) Exempt
Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation