ASSOCIATES OF CAPE COD, INC.

FDA Device Registration & Listing · E Falmouth, MA, US · Registration 1219145

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1219145
FEI Number
1219145
Entity Name
ASSOCIATES OF CAPE COD, INC.
City/State/Country
E Falmouth, MA, US
Establishment Address
124 Bernard E. Saint Jean Drive, E Falmouth, MA 02536, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ASSOCIATES OF CAPE COD, INC. (Owner Number: 1219145)
Owner / Operator Contact Address
124 Bernard E. Saint Jean Drive, East Falmouth, MA 02536, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

BG Analytics Fungitell STAT Fungitell (cleared as Glucatell) FUNGITELL (CLEARED UND PKF08

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2020-08-28
NQZ Antigen, Invasive Fungal Pathogens Microbiology Class 2 866.3050 2020-08-28
NQZ Antigen, Invasive Fungal Pathogens Microbiology Class 2 866.3050 2006-05-09
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use Clinical Chemistry Class 1 862.2300 2025-11-17

Official Correspondent

Debbie Fraser

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ASSOCIATES OF CAPE COD, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K781173 Instrumentation Laboratory CO COMPUTER INTERFACE IL 814 1978-09-14
K760232 Instrumentation Laboratory CO PRINTER, IL 460 1976-08-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-04 Misys Healthcare Systems 1
Calculator/Data Processing Module for Clinical Use
Z-0026-2025 Becton Dickinson & Co. 1
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219145. Last updated year: 2026. Please use registration number 1219145 when referencing this establishment in official correspondence.
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