Medical Device Manufacturer · US , Irvine , CA

Horiba, Ltd.

2 submissions · 2 cleared · Since 2002
2
Total
2
Cleared
0
Denied

Horiba, Ltd. — FDA 510(k) Submissions

Horiba, Ltd. has submitted 2 FDA 510(k) premarket notifications since 2002, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, C-reactive Protein, Analyzer, Chemistry (photometric, Discrete), For Clinical Use . Use the specialty filter in the sidebar to narrow results.

2 devices
1–2 of 2
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All2 Chemistry 1 Immunology 1