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510(k) K191462

Device
Proov Test
Applicant
MFB Fertility, Inc.
510(k) number
K191462
Product code
QKE  
Decision
Substantially Equivalent (SESE)
Decision date
2020-02-27
Date received
2019-06-03
Regulation
862.1620
Classification name
Immunoassay, Pregnanediol Glucuronide, Over The Counter
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Amy Beckley
Address
999 Sumner Way Erie CO US 80516 80516

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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