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FDA 510(k) Application Details - K192858
Device Classification Name
More FDA Info for this Device
510(K) Number
K192858
Device Name
A1AT Genotyping Test
Applicant
Progenika Biopharma S.A., A Grifols Company
Ibaizabal bidea, Edificio 504, Parque Tecnologico de Bizkaia
Derio 48160 ES
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Contact
Diego Tejedor
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PZH
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More FDA Info for this Product Code
Date Received
10/04/2019
Decision Date
11/05/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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