Proov Test

Immunoassay, Pregnanediol Glucuronide, Over The Counter

MFB Fertility, Inc.

The following data is part of a premarket notification filed by Mfb Fertility, Inc. with the FDA for Proov Test.

Pre-market Notification Details

Device IDK191462
510k NumberK191462
Device Name:Proov Test
ClassificationImmunoassay, Pregnanediol Glucuronide, Over The Counter
Applicant MFB Fertility, Inc. 999 Sumner Way Erie,  CO  80516
ContactAmy Beckley
CorrespondentMary Vater
Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury,  VT  05738
Product CodeQKE  
CFR Regulation Number862.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
510k Review PanelClinical Chemistry
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-03
Decision Date2020-02-27

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