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FDA 510(k)

A1AT Genotyping Test

K-Number: K211115 · 2021-05-13

ApplicantProgenika Biopharma S.A., A Grifols Company
Decision Date2021-05-13
Product CodePZH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

A1AT Genotyping Test is the device name listed in this FDA 510(k) record. The listed applicant is Progenika Biopharma S.A., A Grifols Company. It received FDA 510(k) clearance on 2021-05-13 under 510(k) 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. The listed applicant is Progenika Biopharma S.A., A Grifols Company. The 510(k) number is K211115.

When did A1AT Genotyping Test receive FDA 510(k) clearance?

A1AT Genotyping Test received FDA 510(k) clearance on 2021-05-13, under 510(k) number K211115.

Who is the listed applicant for A1AT Genotyping Test?

The FDA 510(k) record lists Progenika Biopharma S.A., A Grifols Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A1AT Genotyping Test?

The FDA product code for A1AT Genotyping Test is PZH.

Other records listing Progenika Biopharma S.A., A Grifols Company as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221420AlphaID™ At Home Genetic Health Risk ServiceK192858A1AT Genotyping TestK171868A1AT Genotyping Test

Related Devices (Code: PZH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192858A1AT Genotyping TestProgenika Biopharma S.A., A Grifols CompanyK171868A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company

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.

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