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510(k) K180099

Optilite High Sensitivity C-Reactive Protein Kit by The Binding Site Group , Ltd. — Product Code DCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2018
Date Received
January 16, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, C-Reactive Protein
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

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