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510(k) K143325

OC-Light S FIT by Eiken Chemical Co., Ltd. — Product Code KHE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2015
Date Received
November 20, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Occult Blood
Device Class
Class II
Regulation Number
864.6550
Review Panel
HE
Submission Type

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