Associates of Cape Cod, Inc.

FDA Regulatory Profile

Associates of Cape Cod, Inc. appears in FDA public data with 2 recalls, 2 510(k) clearances, 12 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1774-2022, Class II) was initiated on August 17, 2022. Its most recent 510(k) clearance was granted on July 17, 2019.

Summary

Total Recalls
2
510(k) Clearances
2
Inspections
12
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1774-2022Class IIFungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007August 17, 2022
Z-1329-2019Class IIFungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimDecember 19, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K191167Fungitell STATJuly 17, 2019
DEN040003GLUCATELLMay 21, 2004