Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013443462

FEI Number

3013443462

Entity Name

MFB FERTILITY, INC.

City/State/Country

Boulder, CO, US

Establishment Address

5485 Conestoga Ct, STE 210, Boulder, CO 80301, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

MFB Fertility, Inc. (Owner Number: 10054102)

Owner / Operator Contact Address

720 Austin Ave, Suite 100-305, Erie, CO 80516, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123703

PMA Number

N/A

All Registered Proprietary Names

Proov Confirm Proov Complete Pregnancy Pack Fertility 4-in-1 Kit Fertility 4-in-1 Kit Proov Empower Perimenopause Test Proov Reserve Proov Complete Proov Check Fertility 4-in-1 Kit Pregnancy Pack Proov Predict, Proov Complete Pregnancy Pack Fertility 4-in-1 Kit Proov Check Early Pregnancy Tests

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKE	Immunoassay, Pregnanediol Glucuronide, Over The Counter	Clinical Chemistry	Class 1	862.1620	2020-03-14
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2018-09-23
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2022-04-10
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2022-04-10
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2018-09-23
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2024-06-19

Official Correspondent

Amy Beckley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MFB Fertility, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K964536	Teco Diagnostics	ONE-STEP DIPSTICK PREGNANCY TEST	1997-02-11
K904016	Bhc Biotech , Ltd.	MAXI TEST	1990-10-15
K870259	Leeco Diagnostics, Inc.	VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044	1987-03-10
K820822	Hybritech, Inc.	TANDEM HCG KIT	1982-04-29
K964108	Direct Access Diagnostics	FACT PLUS PREGNANCY TEST	1996-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01

Similar Registrations

Registration Number	Establishment Name	Location
3030460396	ELI HEALTH	Montreal Quebec, CA
3013587414	Hangzhou Careomedic Tech Co., Ltd.	Hangzhou Zhejiang, CN
3015867318	OOVA, INC.	New York, NY, US
3017904598	Guangzhou Decheng Biotechnology Co., Ltd.	Guangzhou Guangdong, CN
3012725363	EASY HEALTHCARE CORPORATION	Darien, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013443462. Last updated year: 2026. Please use registration number 3013443462 when referencing this establishment in official correspondence.