Ortho Instruments
Country not established
- Devices
- 6
What Ortho Instruments makes
Ortho Instruments manufactures hematology controls and automated cell counters for laboratory use. Their products include liquid controls for normal and abnormal low hematology testing, as well as laser-based hematology systems designed to validate and calibrate blood cell analysis equipment.
The company’s portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) clearance process. These products are listed in the FDA’s 510(k) database and are intended for use in clinical and diagnostic settings within the United States.
Catalogue
Ortho Spectrum Ref K802094
Regimes: 510(k) Registry: 510(k)Ortho Hematology Control Ref K803073
Regimes: 510(k) Registry: 510(k)Ortho Hemotology Control-Normal Ref K803083
Regimes: 510(k) Registry: 510(k)Ortho Automated Cell Counter Ref K801545
Regimes: 510(k) Registry: 510(k)Hemac Laser Hematology System Ref K781146
Regimes: 510(k) Registry: 510(k)Ortho Hematology Control Abnormal Low Ref K803084
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ortho Instruments have in the registry?
The registry currently lists 6 devices for Ortho Instruments. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ortho Instruments's devices?
Among its 6 most recently registered devices, Ortho Instruments has devices listed in FDA 510(k) (6 devices).
What risk classes do Ortho Instruments's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Ortho Instruments's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ortho Instruments in the registry?
The most recently registered devices listed for Ortho Instruments include ORTHO SPECTRUM, ORTHO HEMATOLOGY CONTROL, ORTHO HEMOTOLOGY CONTROL-NORMAL and ORTHO AUTOMATED CELL COUNTER.