QNext And DG-PT

System, Multipurpose For In Vitro Coagulation Studies

Diagnostic Grifols, S.A.

The following data is part of a premarket notification filed by Diagnostic Grifols, S.a. with the FDA for Qnext And Dg-pt.

Pre-market Notification Details

Device IDK183390
510k NumberK183390
Device Name:QNext And DG-PT
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant Diagnostic Grifols, S.A. Passeig Fluvial, 24 Parets Del Valles,  ES 08150
ContactJoaquin Alberto Tamparillas
CorrespondentJoaquin Alberto Tamparillas
Diagnostic Grifols, S.A. Passeig Fluvial, 24 Parets Del Valles,  ES 08150
Product CodeJPA  
Subsequent Product CodeGJS
Subsequent Product CodeGKP
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-06
Decision Date2019-08-21

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