Western Laboratories Corp.
United StatesFDA applicant, unverified
- Devices
- 7
What Western Laboratories Corp. makes
Western Laboratories Corp. manufactures laboratory test instruments for measuring blood chemistry parameters, including devices for bicarbonate conductivity, pressure, temperature, and heparin activity. Their portfolio includes dedicated units for conductivity and temperature testing, as well as specialized analyzers like the Heparinometer for coagulation monitoring.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions supported via 510(k) clearances. Their products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Model 90 Bc Ref K821415
Regimes: 510(k) Registry: 510(k)Model 90 Pressure/Conductivity/Temp Test Ref K801303
Regimes: 510(k) Registry: 510(k)Heparinometer Ref K834024
Regimes: 510(k) Registry: 510(k)Model 200 Ref K830468
Regimes: 510(k) Registry: 510(k)Model 80 Bc Ref K821414
Regimes: 510(k) Registry: 510(k)Model 100 Bicarbonate Conductivity Ref K821834
Regimes: 510(k) Registry: 510(k)Model 80 Conductivity/Temp.test Unit Ref K780932
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Western Laboratories Corp. have in the registry?
The registry currently lists 7 devices for Western Laboratories Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Western Laboratories Corp.'s devices?
Among its 7 most recently registered devices, Western Laboratories Corp. has devices listed in FDA 510(k) (7 devices).
What risk classes do Western Laboratories Corp.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Western Laboratories Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Western Laboratories Corp. in the registry?
The most recently registered devices listed for Western Laboratories Corp. include MODEL 90 BC, MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST, HEPARINOMETER and MODEL 200.