Medical Device Manufacturer · US , Portland , OR

Bioject, Inc.

9 submissions · 9 cleared · Since 1987

Total

Cleared

Denied

Bioject, Inc. — FDA 510(k) Submissions

Bioject, Inc. has submitted 9 FDA 510(k) premarket notifications since 1987, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Injector, Fluid, Non-electrically Powered, Set, I.v. Fluid Transfer . Use the specialty filter in the sidebar to narrow results.

9 devices

1–9 of 9

ZETAJET

K090003 · KZE Injector, Fluid,... · General Hospital

Apr 2009 90d

COOL.CLICK

K050734 · KZE Injector, Fluid,... · General Hospital

Jun 2005 74d

RECONSTITUTION KIT & VIAL CONNECTOR

K010623 · LHI Set, I.v. Fluid Transfer · General Hospital

Apr 2001 34d

SEROJET