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FDA 510(k)

Fungitell STAT

K-Number: K191167 · 2019-07-17

ApplicantAssociates of Cape Cod, Inc.
Decision Date2019-07-17
Product CodeNQZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Fungitell STAT is a medical device manufactured by Associates of Cape Cod, Inc.. It received FDA 510(k) clearance on 2019-07-17 under approval number K191167. The device is classified under product code NQZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fungitell STAT?

Fungitell STAT is a medical device that received FDA 510(k) clearance on 2019-07-17. It is manufactured by Associates of Cape Cod, Inc.. The 510(k) number is K191167.

When was Fungitell STAT approved by the FDA?

Fungitell STAT received FDA 510(k) clearance on 2019-07-17, under approval number K191167.

What company makes Fungitell STAT?

Fungitell STAT is manufactured by Associates of Cape Cod, Inc..

What is the FDA product code for Fungitell STAT?

The FDA product code for Fungitell STAT is NQZ.

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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