Medical Device Manufacturer · US , Abbott Park , IL

Abbott Laboratories Diagnostics Division

4 submissions · 4 cleared · Since 2019
4
Total
4
Cleared
0
Denied

Abbott Laboratories Diagnostics Division — FDA 510(k) Submissions

Abbott Laboratories Diagnostics Division has submitted 4 FDA 510(k) premarket notifications since 2019, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Immunoassay Method, Troponin Subunit, Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes . Use the specialty filter in the sidebar to narrow results.

4 devices
1–4 of 4
Filters
Filter by Specialty
All4 Chemistry 4