A1AT Genotyping Test
K-Number: K211115 · 2021-05-13
Decision Date2021-05-13
Product CodePZH
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
A1AT Genotyping Test is a medical device manufactured by Progenika Biopharma S.A., A Grifols Company. It received FDA 510(k) clearance on 2021-05-13 under approval number K211115. The device is classified under product code PZH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the A1AT Genotyping Test?
A1AT Genotyping Test is a medical device that received FDA 510(k) clearance on 2021-05-13. It is manufactured by Progenika Biopharma S.A., A Grifols Company. The 510(k) number is K211115.
When was A1AT Genotyping Test approved by the FDA?
A1AT Genotyping Test received FDA 510(k) clearance on 2021-05-13, under approval number K211115.
What company makes A1AT Genotyping Test?
A1AT Genotyping Test is manufactured by Progenika Biopharma S.A., A Grifols Company.
What is the FDA product code for A1AT Genotyping Test?
The FDA product code for A1AT Genotyping Test is PZH.
Other Devices by Progenika Biopharma S.A., A Grifols Company
Related Devices (Code: PZH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.