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510(k) K160070

Rheumatoid Factor (RF) Kit for use on SPAPLUS by The Binding Site Group , Ltd. — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2016
Date Received
January 13, 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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