FDA Registration
Active
🇺🇸 United States
Abacus 3CP
Reg #: 3008425728
·
FEI: 3008425728
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DIATRON US INC
- Registration Number
- 3008425728
- FEI Number
- 3008425728
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 12601 NW 115th Avenue, Suite A 113
- City
- Medley
- State
- FL
- ZIP
- 33178
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111534
Owner / Operator
- Firm Name
- Diatron U.S. Inc
- Operator Number
- 10037043
- Address
- 12601 NW 115th Avenue Suite A 113
- City
- Medley
- State
- FL
- Postal Code
- 33178
- Country
- US
- Correspondent
- Frank Matuszak
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Counter, Differential Cell | GKZ | Class 2 | Hematology | No | 2012-08-07 |
Proprietary Names
Abacus 3CP
Establishment Types
Repack or Relabel Medical Device