K-number	K211115
Device name	A1AT Genotyping Test
Applicant	Progenika Biopharma S.A., A Grifols Company
Product code	PZH
Device class	Class II
Decision date	May 13, 2021
Decision	Substantially Equivalent
Regulation	866.5130

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Source

View the full FDA submission: accessdata.fda.gov

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A1AT Genotyping Test

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