Medical Device Manufacturer · US , Malvern , PA

Fujirebio Dianostics, Inc.

1 submissions · 1 cleared · Since 2019
1
Total
1
Cleared
0
Denied

Fujirebio Dianostics, Inc. — FDA 510(k) Submissions

Fujirebio Dianostics, Inc. has submitted 1 FDA 510(k) premarket notifications since 2019, of which 1 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer . Use the specialty filter in the sidebar to narrow results.

1 devices
1–1 of 1
Filters
All1 Immunology 1