Data / Medical devices / United States / Associates Of Cape Cod, Inc.
Associates Of Cape Cod, Inc.: FDA-registered device maker in E Falmouth, MA, United States, 2 510(k) clearances
Associates Of Cape Cod, Inc. is registered with the FDA (registration 1219145) in E Falmouth, MA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 17, 2019. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1219145
- Address
- 124 Bernard E. Saint Jean Drive, E Falmouth, MA, United States, 02536
- Owner or operator
- ASSOCIATES OF CAPE COD, INC. (1219145)
- Roles
- Manufacturer
- First device listed
- May 9, 2006
- Registered through
- 2027
- Brand names listed
- BG Analytics, FUNGITELL (CLEARED UND, Fungitell (cleared as Glucatell), Fungitell STAT, PKF08
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigen, Invasive Fungal Pathogens | NQZ | 2 | Manufacturer | accessdata.fda.gov |
| Calculator/Data Processing Module, For Clinical Use | JQP | 1 | Manufacturer | accessdata.fda.gov |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 17, 2019 | K191167 | Fungitell STAT | NQZ | Substantially Equivalent | Associates of Cape Cod, Inc. | accessdata.fda.gov |
| May 21, 2004 | DEN040003 | GLUCATELL | NQZ | Unknown | Associates of Cape Cod, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 17, 2022 | 90820 | Class II | Terminated | Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007 | Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes | accessdata.fda.gov |
| December 19, 2018 | 82551 | Class II | Terminated | Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detection of (1-3)Beta-D Glucan in the serum of patients with symptoms of,or medical con | The kits may contain the incorrect number of components or the kits may be missing components. | accessdata.fda.gov |
Compare with other makers
- All makers of Calculator/Data Processing Module, For Clinical Use
- All makers of Colorimeter, Photometer, Spectrophotometer For Clinical Use
Updated July 17, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.