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FDA 510(k)

AmCAD-UO

K-Number: K180867 · 2018-12-28

ApplicantAmcad Biomed Corporation
Decision Date2018-12-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AmCAD-UO is a medical device manufactured by Amcad Biomed Corporation. It received FDA 510(k) clearance on 2018-12-28 under approval number K180867. 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-UO?

AmCAD-UO is a medical device that received FDA 510(k) clearance on 2018-12-28. It is manufactured by Amcad Biomed Corporation. The 510(k) number is K180867.

When was AmCAD-UO approved by the FDA?

AmCAD-UO received FDA 510(k) clearance on 2018-12-28, under approval number K180867.

What company makes AmCAD-UO?

AmCAD-UO is manufactured by Amcad Biomed Corporation.

What is the FDA product code for AmCAD-UO?

The FDA product code for AmCAD-UO is LLZ.

Other Devices by Amcad Biomed Corporation

K162574AmCAD-US K170069AmCAD-UV K180006AmCAD-UT Detection 2.2 K203555AmCAD-UT

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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