Medical Device Manufacturer · JP , Taito-Ku

Eiken Chemical Co., Ltd.

2 submissions · 2 cleared · Since 2015
2
Total
2
Cleared
0
Denied

Eiken Chemical Co., Ltd. — FDA 510(k) Submissions

Eiken Chemical Co., Ltd. has submitted 2 FDA 510(k) premarket notifications since 2015, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Reagent, Occult Blood, Automated Occult Blood Analyzer . Use the specialty filter in the sidebar to narrow results.

2 devices
1–2 of 2
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All2 Hematology 2