A1AT Genotyping Test

Serpina1 Variant Detection System

Progenika Biopharma S.A., A Grifols Company

The following data is part of a premarket notification filed by Progenika Biopharma S.a., A Grifols Company with the FDA for A1at Genotyping Test.

Pre-market Notification Details

Device IDK192858
501k NumberK192858
Device Name:A1AT Genotyping Test
ClassificationSerpina1 Variant Detection System
Applicant Progenika Biopharma S.A., A Grifols Company Ibaizabal Bidea, Edificio 504, Parque Tecnologico De Bizkaia Derio,  ES 48160
ContactDiego Tejedor
CorrespondentDiego Tejedor
Progenika Biopharma S.A., A Grifols Company Ibaizabal Bidea, Edificio 504, Parque Tecnologico De Bizkaia Derio,  ES 48160
Product CodePZH  
CFR Regulation Number866.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyImmunology
501k Review PanelImmunology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-04
Decision Date2019-11-05

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