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510(k) K192858

Device
A1AT Genotyping Test
Applicant
Progenika Biopharma S.A., A Grifols Company
510(k) number
K192858
Product code
PZH  
Decision
Substantially Equivalent (SESE)
Decision date
2019-11-05
Date received
2019-10-04
Regulation
866.5130
Classification name
Serpina1 Variant Detection System
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Diego Tejedor
Address
Ibaizabal Bidea, Edificio 504, Parque Tecnologico De Bizkaia Derio ES 48160 48160

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PZH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K211115A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company2021-05-13
K171868A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company2017-11-11

Legacy Summary#

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FDA Review#

Decision Summary