The following data is part of a premarket notification filed by Mfb Fertility, Inc. with the FDA for Proov Test.
| Device ID | K191462 |
| 510k Number | K191462 |
| Device Name: | Proov Test |
| Classification | Immunoassay, Pregnanediol Glucuronide, Over The Counter |
| Applicant | MFB Fertility, Inc. 999 Sumner Way Erie, CO 80516 |
| Contact | Amy Beckley |
| Correspondent | Mary Vater Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, VT 05738 |
| Product Code | QKE |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-03 |
| Decision Date | 2020-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002790817 | K191462 | 000 |