FDA Registration
Active
🇺🇸 United States
PATHFAST NTproBNP
Reg #: 2435505
·
FEI: 1000119795
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC.
- Registration Number
- 2435505
- FEI Number
- 1000119795
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 510 FURNACE DOCK RD.
- City
- CORTLANDT MANOR
- State
- NY
- ZIP
- 10567
- Country
- US
Regulatory Submissions
- 510(k) Number
- K072189
Owner / Operator
- Firm Name
- POLYMEDCO, INC.
- Operator Number
- 9001475
- Address
- 510 FURNACE DOCK RD., --
- City
- Cortlandt Manor
- State
- NY
- Postal Code
- 10567
- Country
- US
- Correspondent
- Todd - Kelley
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Natriuretic Peptide | NBC | Class 2 | Clinical Chemistry | No | 2017-06-27 |
Proprietary Names
PATHFAST NTproBNP
Establishment Types
Complaint File Establishment per 21 CFR 820.198