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FDA 510(k)

PGDx elio tissue complete

K-Number: K192063 · 2020-04-24

ApplicantPersonal Genome Diagnostics
Decision Date2020-04-24
Product CodePZM
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

PGDx elio tissue complete is a medical device manufactured by Personal Genome Diagnostics. It received FDA 510(k) clearance on 2020-04-24 under approval number K192063. The device is classified under product code PZM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PGDx elio tissue complete?

PGDx elio tissue complete is a medical device that received FDA 510(k) clearance on 2020-04-24. It is manufactured by Personal Genome Diagnostics. The 510(k) number is K192063.

When was PGDx elio tissue complete approved by the FDA?

PGDx elio tissue complete received FDA 510(k) clearance on 2020-04-24, under approval number K192063.

What company makes PGDx elio tissue complete?

PGDx elio tissue complete is manufactured by Personal Genome Diagnostics.

What is the FDA product code for PGDx elio tissue complete?

The FDA product code for PGDx elio tissue complete is PZM.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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