K191462 is an FDA 510(k) clearance for the Proov Test. This device is classified as a Immunoassay, Pregnanediol Glucuronide, Over The Counter (Class I - General Controls, product code QKE).
Submitted by Mfb Fertility, Inc. (Erie, US). The FDA issued a Cleared decision on February 27, 2020, 269 days after receiving the submission on June 3, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1620. Over-the-counter Detection Of Pregnanediol Glucuronide For The Confirmation Of Ovulation.
| 510(k) Number | K191462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2019 |
| Decision Date | February 27, 2020 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | QKE - Immunoassay, Pregnanediol Glucuronide, Over The Counter |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1620 |
| Definition | Over-the-counter Detection Of Pregnanediol Glucuronide For The Confirmation Of Ovulation |