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FDA 510(k)

ACCUDXA2

K-Number: K113616 · 2012-04-27

ApplicantLone Oak Medical Technologies, LLC
Decision Date2012-04-27
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCUDXA2 is the device name listed in this FDA 510(k) record. The listed applicant is Lone Oak Medical Technologies, LLC. It received FDA 510(k) clearance on 2012-04-27 under 510(k) number K113616. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUDXA2?

ACCUDXA2 is a medical device that received FDA 510(k) clearance on 2012-04-27. The listed applicant is Lone Oak Medical Technologies, LLC. The 510(k) number is K113616.

When did ACCUDXA2 receive FDA 510(k) clearance?

ACCUDXA2 received FDA 510(k) clearance on 2012-04-27, under 510(k) number K113616.

Who is the listed applicant for ACCUDXA2?

The FDA 510(k) record lists Lone Oak Medical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUDXA2?

The FDA product code for ACCUDXA2 is KGI.

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Related Devices (Code: KGI)

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.

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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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