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FDA 510(k)

TruDiagnosis System

K-Number: K183530 · 2019-05-24

ApplicantAkonni Biosystems, Inc.
Decision Date2019-05-24
Product CodeODW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TruDiagnosis System is the device name listed in this FDA 510(k) record. The listed applicant is Akonni Biosystems, Inc.. It received FDA 510(k) clearance on 2019-05-24 under 510(k) number K183530. The device is classified under product code ODW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TruDiagnosis System?

TruDiagnosis System is a medical device that received FDA 510(k) clearance on 2019-05-24. The listed applicant is Akonni Biosystems, Inc.. The 510(k) number is K183530.

When did TruDiagnosis System receive FDA 510(k) clearance?

TruDiagnosis System received FDA 510(k) clearance on 2019-05-24, under 510(k) number K183530.

Who is the listed applicant for TruDiagnosis System?

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

What is the FDA product code for TruDiagnosis System?

The FDA product code for TruDiagnosis System is ODW.

Related Devices (Code: ODW)

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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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