Hematronix, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Hematronix, Inc. makes
Hematronix, Inc. makes hematology and urine testing devices including the TRI-COUNT 16 and TRI-COUNT 20 blood cell counters, RETIC-QUINOX reticulocyte analyzer, MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL for urine quality control, QUANTIFY(901) analyzer, METER TRAX and EZ-RANGE calibration or testing systems, and CENTRIFIQ BLOOD CONTROL for blood testing quality assurance.
The company's devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry. Hematronix, Inc. is based in the United States.
Catalogue
Tri-Count 16 Ref K902389
Regimes: 510(k) Registry: 510(k)Retic-Quinox Ref K993496
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Quantify(901) Ref K972710
Regimes: 510(k) Registry: 510(k)Meter Trax Ref K904461
Regimes: 510(k) Registry: 510(k)Ez-Range Ref K941965
Regimes: 510(k) Registry: 510(k)Centrifiq Blood Control Ref K935343
Regimes: 510(k) Registry: 510(k)Tri-Court 20-T Ref K960005
Regimes: 510(k) Registry: 510(k)Tri-Count 20 Ref K960471
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hematronix, Inc. have in the registry?
The registry currently lists 9 devices for Hematronix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hematronix, Inc.'s devices?
Among its 9 most recently registered devices, Hematronix, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Hematronix, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Hematronix, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hematronix, Inc. in the registry?
The most recently registered devices listed for Hematronix, Inc. include TRI-COUNT 16, RETIC-QUINOX, MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL and QUANTIFY(901).