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FDA 510(k)

Proov Test

K-Number: K191462 · 2020-02-27

Decision Date2020-02-27
Product CodeQKE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Proov Test is a medical device manufactured by Mfb Fertility, Inc.. It received FDA 510(k) clearance on 2020-02-27 under approval 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. It is manufactured by Mfb Fertility, Inc.. The 510(k) number is K191462.

When was Proov Test approved by the FDA?

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

What company makes Proov Test?

Proov Test is manufactured by Mfb Fertility, Inc..

What is the FDA product code for Proov Test?

The FDA product code for Proov Test is QKE.

Official Source

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