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510(k) K162723

TransFix/EDTA Vacuum Blood Collection Tubes by Caltag Medsystems, Ltd. — Product Code GIM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2017
Date Received
September 29, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vacuum Sample, With Anticoagulant
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

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