510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191167Substantially Equivalent

Fungitell STAT

Associates of Cape Cod, Inc., East Falmouth MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191167 is the FDA 510(k) clearance record for Fungitell STAT, a class II device, cleared for Associates of Cape Cod, Inc. on under FDA product code NQZ (Antigen, Invasive Fungal Pathogens). FDA's definition for product code NQZ reads: "Invasive fungal pathogen assays are devices that consist of antigens, antisera, or proteases used in serological assays for the presumptive diagnosis of fungal infection in serum or plasma. The assay is indicated for use in patients with...". FDA records list 2 510(k) clearances for Associates of Cape Cod, Inc., from to . As of , FDA records show one recall naming K191167.

Clearance record

Decision date
Received
(77 days to decision)
Product code
NQZ Antigen, Invasive Fungal Pathogens
Regulation
21 CFR 866.3050
Device class
Class II
Review panel
Microbiology
Applicant
Associates of Cape Cod, Inc. 124 Bernard E. Saint Jean Dr., East Falmouth MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NQZ

Trailing 12 months

FDA records hold no clearances under product code NQZ in the trailing twelve months.

FDA records show no clearances under product code NQZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NQZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260