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510(k) K183390

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

K183390 is an FDA 510(k) premarket notification submitted by Diagnostic Grifols, S.A. for the device "QNext and DG-PT". The FDA issued a decision of Substantially Equivalent on August 21, 2019. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425.

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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FDA data resources