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510(k) K162263

Optilite Rheumatoid Factor Kit by The Binding Site Group , Ltd. — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2017
Date Received
August 11, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Rheumatoid Factor
Device Class
Class II
Regulation Number
866.5775
Review Panel
IM
Submission Type

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