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FDA 510(k)

Concentriq Dx

K-Number: K230839 · 2024-02-08

ApplicantProscia, Inc.
Decision Date2024-02-08
Product CodePSY
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

Concentriq Dx is a medical device manufactured by Proscia, Inc.. It received FDA 510(k) clearance on 2024-02-08 under approval number K230839. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Concentriq Dx?

Concentriq Dx is a medical device that received FDA 510(k) clearance on 2024-02-08. It is manufactured by Proscia, Inc.. The 510(k) number is K230839.

When was Concentriq Dx approved by the FDA?

Concentriq Dx received FDA 510(k) clearance on 2024-02-08, under approval number K230839.

What company makes Concentriq Dx?

Concentriq Dx is manufactured by Proscia, Inc..

What is the FDA product code for Concentriq Dx?

The FDA product code for Concentriq Dx is PSY.

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Official Source

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