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FDA 510(k)

AlphaID™ At Home Genetic Health Risk Service

K-Number: K221420 · 2022-10-27

ApplicantProgenika Biopharma S.A., A Grifols Company
Decision Date2022-10-27
Product CodePTA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AlphaID™ At Home Genetic Health Risk Service 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 2022-10-27 under 510(k) number K221420. The device is classified under product code PTA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AlphaID™ At Home Genetic Health Risk Service?

AlphaID™ At Home Genetic Health Risk Service is a medical device that received FDA 510(k) clearance on 2022-10-27. The listed applicant is Progenika Biopharma S.A., A Grifols Company. The 510(k) number is K221420.

When did AlphaID™ At Home Genetic Health Risk Service receive FDA 510(k) clearance?

AlphaID™ At Home Genetic Health Risk Service received FDA 510(k) clearance on 2022-10-27, under 510(k) number K221420.

Who is the listed applicant for AlphaID™ At Home Genetic Health Risk Service?

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 AlphaID™ At Home Genetic Health Risk Service?

The FDA product code for AlphaID™ At Home Genetic Health Risk Service is PTA.

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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.

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Related Devices (Code: PTA)

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.

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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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