FDA Registration
Active
🇺🇸 United States
DIATRON US INC
Reg #: 3008425728
·
FEI: 3008425728
·
Expires 2026
Products
5
Proprietary Names
21
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- DIATRON US INC
- Registration Number
- 3008425728
- FEI Number
- 3008425728
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 12601 NW 115th Avenue, Suite A 113
- City
- Medley
- State
- FL
- ZIP
- 33178
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112755
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 |
|---|---|---|---|---|---|
| Diluent, Blood Cell | GIF | Class 1 | Hematology | No | 2014-08-29 |
| Counter, Differential Cell | GKZ | Class 2 | Hematology | No | 2012-04-03 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2015-08-08 |
| Products, Red-Cell Lysing Products | GGK | Class 1 | Hematology | No | 2014-08-29 |
| Detergent | JCB | Class 1 | Pathology | No | 2014-08-29 |
Proprietary Names
Diatro Dil DIFF
Diatro Dil 5P
Abacus 5
Abacus 3CP
P500, Diatron Pictus 500
APK300, Autopak 300 Clinical Chemistry Autoanalyzer
Pictus 700 Clinical Chemistry Analyzer
P780 Clinical Chemistry Analyzer
Diatro Lyse 5P
Diatro Diff 5P
Diatro Lyse DIFF
5x TBS Wash Buffer
Solution 3 Additive for Wash Solution
Solution1 Hypochlorite Cleaning Solution
Diatro Hypoclean
Cleaning Solution Cleaning kit
Diatro Hypoclean CC
Additive for wash solution
Diatro Cleaner
Cuvette Cleaner Solutions
Solution 2 Rinsing Solution
Establishment Types
Repack or Relabel Medical Device