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510(k) K183390

QNext and DG-PT by Diagnostic Grifols, S.A. — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2019
Date Received
December 6, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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