FDA 510(k)

Concentriq Dx

K-Number: K230839 · 2024-02-08

Decision Date2024-02-08

Product CodePSY

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

Concentriq Dx is the device name listed in this FDA 510(k) record. The listed applicant is Proscia, Inc.. It received FDA 510(k) clearance on 2024-02-08 under 510(k) 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. The listed applicant is Proscia, Inc.. The 510(k) number is K230839.

When did Concentriq Dx receive FDA 510(k) clearance?

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

Who is the listed applicant for Concentriq Dx?

The FDA 510(k) record lists Proscia, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Concentriq Dx?

The FDA product code for Concentriq Dx is PSY.

Other records listing Proscia, Inc. 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.

K261380Concentriq AP-Dx

Related Devices (Code: PSY)

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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.