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FDA 510(k)

AMCAD-UT DETECTION MODEL 2.0

K-Number: K122536 · 2013-10-03

ApplicantLin & Associates, LLC
Decision Date2013-10-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AMCAD-UT DETECTION MODEL 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Lin & Associates, LLC. It received FDA 510(k) clearance on 2013-10-03 under 510(k) number K122536. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMCAD-UT DETECTION MODEL 2.0?

AMCAD-UT DETECTION MODEL 2.0 is a medical device that received FDA 510(k) clearance on 2013-10-03. The listed applicant is Lin & Associates, LLC. The 510(k) number is K122536.

When did AMCAD-UT DETECTION MODEL 2.0 receive FDA 510(k) clearance?

AMCAD-UT DETECTION MODEL 2.0 received FDA 510(k) clearance on 2013-10-03, under 510(k) number K122536.

Who is the listed applicant for AMCAD-UT DETECTION MODEL 2.0?

The FDA 510(k) record lists Lin & Associates, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMCAD-UT DETECTION MODEL 2.0?

The FDA product code for AMCAD-UT DETECTION MODEL 2.0 is LLZ.

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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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