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FDA 510(k)

Proov Test

K-Number: K191462 · 2020-02-27

ApplicantMfb Fertility, Inc.
Decision Date2020-02-27
Product CodeQKE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Proov Test is the device name listed in this FDA 510(k) record. The listed applicant is Mfb Fertility, Inc.. It received FDA 510(k) clearance on 2020-02-27 under 510(k) number K191462. The device is classified under product code QKE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Proov Test?

Proov Test is a medical device that received FDA 510(k) clearance on 2020-02-27. The listed applicant is Mfb Fertility, Inc.. The 510(k) number is K191462.

When did Proov Test receive FDA 510(k) clearance?

Proov Test received FDA 510(k) clearance on 2020-02-27, under 510(k) number K191462.

Who is the listed applicant for Proov Test?

The FDA 510(k) record lists Mfb Fertility, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Proov Test?

The FDA product code for Proov Test is QKE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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