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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay, Pregnanediol Glucuronide, Over The Counter
510(k) Number K191462
Device Name Proov Test
Applicant
Mfb Fertility, Inc.
999 Sumner Way
Erie,  CO  80516
Applicant Contact Amy Beckley
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Mary Vater
Regulation Number862.1620
Classification Product Code
QKE  
Date Received06/03/2019
Decision Date 02/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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