FDA Registration
Active
🇺🇸 United States
ASSOCIATES OF CAPE COD, INC.
Reg #: 1219145
·
FEI: 1219145
·
Expires 2026
Products
3
Proprietary Names
5
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ASSOCIATES OF CAPE COD, INC.
- Registration Number
- 1219145
- FEI Number
- 1219145
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 124 Bernard E. Saint Jean Drive
- City
- E Falmouth
- State
- MA
- ZIP
- 02536
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191167
Owner / Operator
- Firm Name
- ASSOCIATES OF CAPE COD, INC.
- Operator Number
- 1219145
- Address
- 124 Bernard E. Saint Jean Drive
- City
- East Falmouth
- State
- MA
- Postal Code
- 02536
- Country
- US
- Correspondent
- Debbie - Fraser
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2020-08-28 |
| Antigen, Invasive Fungal Pathogens | NQZ | Class 2 | Microbiology | No | 2020-08-28 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2025-11-17 |
Proprietary Names
BG Analytics
Fungitell STAT
Fungitell (cleared as Glucatell)
FUNGITELL (CLEARED UND
PKF08
Establishment Types
Manufacture Medical Device