510(k) K213690

Eclipse Blood Collection Set by Eclipse Medcorp, LLC — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2022
Date Received
November 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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