FDA Registration
Active
🇺🇸 United States
BD FACSPresto System
Reg #: 3027394506
·
FEI: 3027394506
·
Expires 2025
Products
4
Proprietary Names
3
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- Becton, Dickinson and Company, BD Biosciences
- Registration Number
- 3027394506
- FEI Number
- 3027394506
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 155 North McCarthy Boulevard
- City
- Milpitas
- State
- CA
- ZIP
- 95035
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150815
Owner / Operator
- Firm Name
- Becton Dickinson and Company
- Operator Number
- 9922032
- Address
- One Becton Drive
- City
- Franklin Lakes
- State
- NJ
- Postal Code
- 07417
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mixture, Hematology Quality Control | JPK | Class 2 | Hematology | No | 2015-12-22 |
| Flow Cytometric Reagents And Accessories. | OYE | Class 2 | Hematology | No | 2015-12-22 |
| Counter, Cell, Automated (Particle Counter) | GKL | Class 2 | Hematology | No | 2015-12-22 |
| Automated Multicolor Fluorescent Imaging Cytometric Analysis System | PMG | Class 2 | Hematology | No | 2015-12-22 |
Proprietary Names
BD FACSPresto System
BD FACSPresto CD4/Hb Cartridge
BD FACSPresto CD4/Hb Cartridge Kit
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198