FDA 510(k) Application Details - K211115

Device Classification Name	More FDA Info for this Device
510(K) Number	K211115
Device Name	A1AT Genotyping Test
Applicant	Progenika Biopharma S.A., a Grifols company Ibaizabal bidea, Edificio 504, Parque Tecnol≤gico de Bizkaia Derio 48160 ES Other 510(k) Applications for this Company
Contact	Diego Tejedor Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2021
Decision Date	05/13/2021
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