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510(k) K162233

Kurin Blood Culture Collection Set by Pathway, LLC — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2016
Date Received
August 8, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

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