Data / Medical devices / Hungary / Diatron MI Plc
Diatron MI Plc: FDA-registered device maker in Budapest, Hungary, 1 510(k) clearance
Diatron MI Plc is registered with the FDA (registration 3009297077) in Budapest, Hungary. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 27, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009297077
- Address
- Tablas str. 39, Budapest, Hungary, H-1097
- Owner or operator
- Diatron MI Plc (10040448)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 16, 2012
- Registered through
- 2026
- Brand names listed
- 5x TBS Wash Buffer, APK300, Autopak 300 Clinical Chemistry Autoanalyzer, Abacus 5 Autoloader, Abacus 5 Hematology Analyzer, Additive for wash solution, Cleaning Solution, Cleaning kit, Cuvette Cleaner and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Manufacturer | accessdata.fda.gov |
| Counter, Differential Cell | GKZ | 2 | Manufacturer | accessdata.fda.gov |
| Detergent | JCB | 1 | Manufacturer | accessdata.fda.gov |
| Diluent, Blood Cell | GIF | 1 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Products, Red-Cell Lysing Products | GGK | 1 | Manufacturer | accessdata.fda.gov |
| Real Time Nucleic Acid Amplification System | OOI | 2 | Contract manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 27, 2012 | K112755 | ABACUS 5 | GKZ | Substantially Equivalent | Diatron U.S., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- All makers of Diluent, Blood Cell
- All makers of Real Time Nucleic Acid Amplification System
- All makers of General Purpose Reagent
- All makers of Counter, Differential Cell
- All makers of Products, Red-Cell Lysing Products
Updated March 27, 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.