A1AT Genotyping Test
K-Number: K171868 · 2017-11-11
Device Summary
Frequently Asked Questions
What is the A1AT Genotyping Test?
A1AT Genotyping Test is a medical device that received FDA 510(k) clearance on 2017-11-11. The listed applicant is Progenika Biopharma S.A., A Grifols Company. The 510(k) number is K171868.
When did A1AT Genotyping Test receive FDA 510(k) clearance?
A1AT Genotyping Test received FDA 510(k) clearance on 2017-11-11, under 510(k) number K171868.
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.
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.
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.