Data / Medical devices / United States / MFB Fertility, Inc.
MFB Fertility, Inc.: FDA-registered device maker in Boulder, CO, United States, 3 510(k) clearances
MFB Fertility, Inc. is registered with the FDA (registration 3013443462) in Boulder, CO, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 27, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013443462
- Address
- 5485 Conestoga Ct STE 210, Boulder, CO, United States, 80301
- Owner or operator
- MFB Fertility, Inc. (10054102)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- September 23, 2018
- Registered through
- 2026
- Brand names listed
- Fertility 4-in-1 Kit, Pregnancy Pack, Proov Check, Proov Check Early Pregnancy Tests, Proov Complete, Proov Confirm, Proov Empower Perimenopause Test, Proov Predict, Proov Complete and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Immunoassay, Pregnanediol Glucuronide, Over The Counter | QKE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Complaint file establishment | accessdata.fda.gov |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 27, 2020 | K191462 | Proov Test | QKE | Substantially Equivalent | Mfb Fertility, Inc. | accessdata.fda.gov |
| February 22, 2019 | K181551 | DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette | LCX | Substantially Equivalent | Runbio Biotech Co.,Ltd | accessdata.fda.gov |
| April 10, 2013 | K123703 | HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) | LCX | Substantially Equivalent | Healgen Scientific,, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Visual, Pregnancy Hcg, Prescription Use
- All makers of Immunoassay, Pregnanediol Glucuronide, Over The Counter
- All makers of Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Updated February 27, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.