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 the device name listed in this FDA 510(k) record. The listed applicant is Associates of Cape Cod, Inc.. It received FDA 510(k) clearance on 2019-07-17 under 510(k) 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. The listed applicant is Associates of Cape Cod, Inc.. The 510(k) number is K191167.
When did Fungitell STAT receive FDA 510(k) clearance?
Fungitell STAT received FDA 510(k) clearance on 2019-07-17, under 510(k) number K191167.
Who is the listed applicant for Fungitell STAT?
The FDA 510(k) record lists Associates of Cape Cod, Inc. as the applicant. This does not by itself establish the device manufacturer.
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.