A1AT Genotyping Test— 510(k) K192858

Name: FDA 510(k) clearance K192858
Creator: U.S. Food and Drug Administration
Published: 2019-11-05

Substantially Equivalent

Progenika Biopharma S.A., A Grifols Company

FDA 510(k) clearance K192858 for A1AT Genotyping Test, Substantially Equivalent on 2019-11-05. Applicant: Progenika Biopharma S.A., A Grifols Company. Device class: 2.

Clearance details

Applicant: Progenika Biopharma S.A., A Grifols Company
Product code: Code PZH
Device class: Class 2
Regulation: 21 CFR 866.5130
Advisory panel: Immunology
Date received: 2019-10-04
Decision date: 2019-11-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Derio, ES

Download summary PDF View on FDA.gov ↗

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