FDA 510(k)

Concentriq AP-Dx

K-Number: K261380 · 2026-08-05

Decision Date2026-08-05

Product CodeQKQ

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

Concentriq AP-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 2026-08-05 under 510(k) number K261380. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Concentriq AP-Dx?

Concentriq AP-Dx is a medical device that received FDA 510(k) clearance on 2026-08-05. The listed applicant is Proscia, Inc.. The 510(k) number is K261380.

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

Concentriq AP-Dx received FDA 510(k) clearance on 2026-08-05, under 510(k) number K261380.

Who is the listed applicant for Concentriq AP-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 AP-Dx?

The FDA product code for Concentriq AP-Dx is QKQ.

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.

K230839Concentriq Dx

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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.