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FDA 510(k)

AmCAD-UT

K-Number: K203555 · 2021-09-08

ApplicantAmcad Biomed Corporation
Decision Date2021-09-08
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AmCAD-UT is a medical device manufactured by Amcad Biomed Corporation. It received FDA 510(k) clearance on 2021-09-08 under approval number K203555. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AmCAD-UT?

AmCAD-UT is a medical device that received FDA 510(k) clearance on 2021-09-08. It is manufactured by Amcad Biomed Corporation. The 510(k) number is K203555.

When was AmCAD-UT approved by the FDA?

AmCAD-UT received FDA 510(k) clearance on 2021-09-08, under approval number K203555.

What company makes AmCAD-UT?

AmCAD-UT is manufactured by Amcad Biomed Corporation.

What is the FDA product code for AmCAD-UT?

The FDA product code for AmCAD-UT is QIH.

Other Devices by Amcad Biomed Corporation

K162574AmCAD-US K170069AmCAD-UV K180867AmCAD-UO K180006AmCAD-UT Detection 2.2

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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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