Associates of Cape Cod, Inc.
E Falmouth, MA, US
ASSOCIATES OF CAPE COD, INC. appears in FDA device records in E Falmouth, MA. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Associates of Cape Cod, Inc. between 2004 and 2019. The busiest year on record is 2004, with 1. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2019 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1219145 | 1219145 | ASSOCIATES OF CAPE COD, INC. | 124 Bernard E. Saint Jean Drive, E Falmouth, MA 02536 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1774-2022 | 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 | Class II | Terminated | |
| Z-1329-2019 | 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 conditions predisposing the patient to, invasive fungal infection. The serum concentration of (1-3)Beta-D Glucan, a major cell wall component of various medically important fungi, can be used as an aid in teh diagnosis of deep-seated mycoses and funemias. A positve result does not indicate which genus of fungi may be causing the infection. (1-3)Beta-D Glucan titers should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination. | The kits may contain the incorrect number of components or the kits may be missing components. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain