FDA applicant

Associates of Cape Cod, Inc.

Woodbury, MN2 decisions2004–20191 recall

FDA records 2 decisions for Associates of Cape Cod, Inc. (Woodbury, MN) from 2004 to 2019: 1 510(k) clearance and 1 De Novo grant. All are in product code NQZ (Antigen, Invasive Fungal Pathogens). Its devices cite 1 predicate, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Associates of Cape Cod, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007high 1 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2022

2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Associates of Cape Cod, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Associates”

FDA records each applicant name separately; these may or may not be the same firm.

Associates IN Radiology, Inc. 1 Associates IN Biofeedback 1

Associates of Cape Cod, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Associates”