Medical Device Manufacturer · US , Lexington , MA

Instrumentation Laboratory

3 submissions · 3 cleared · Since 2008
3
Total
3
Cleared
0
Denied

Instrumentation Laboratory — FDA 510(k) Submissions

Instrumentation Laboratory has submitted 3 FDA 510(k) premarket notifications since 2008, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plasma, Coagulation Control, System, Multipurpose For In Vitro Coagulation Studies, Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control . Use the specialty filter in the sidebar to narrow results.

3 devices
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