Data / Medical devices / United States / Diatron Us Inc
Diatron Us Inc: FDA-registered device maker in Medley, FL, United States, 2 510(k) clearances
Diatron Us Inc is registered with the FDA (registration 3008425728) in Medley, FL, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 2, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008425728
- Address
- 12601 NW 115th Avenue Suite A 113, Medley, FL, United States, 33178
- Owner or operator
- Diatron U.S. Inc (10037043)
- Roles
- Repackager or relabeler
- First device listed
- April 3, 2012
- Registered through
- 2026
- Brand names listed
- 5x TBS Wash Buffer, APK300, Autopak 300 Clinical Chemistry Autoanalyzer, Abacus 3CP, Abacus 5, Additive for wash solution, Cleaning Solution Cleaning kit, Cuvette Cleaner Solutions, Diatro Cleaner and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Counter, Differential Cell | GKZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Detergent | JCB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Diluent, Blood Cell | GIF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Products, Red-Cell Lysing Products | GGK | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 2, 2012 | K111534 | ABACUS 3CP | GKZ | Substantially Equivalent | Diatron U.S., Inc. | accessdata.fda.gov |
| March 27, 2012 | K112755 | ABACUS 5 | GKZ | Substantially Equivalent | Diatron U.S., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Diluent, Blood Cell
- All makers of Products, Red-Cell Lysing Products
- All makers of Counter, Differential Cell
- All makers of Detergent
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Updated August 2, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.