FDA 510(k)

AmCAD-US

K-Number: K162574 · 2017-05-30

Decision Date2017-05-30

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AmCAD-US is the device name listed in this FDA 510(k) record. The listed applicant is Amcad Biomed Corporation. It received FDA 510(k) clearance on 2017-05-30 under 510(k) number K162574. 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-US?

AmCAD-US is a medical device that received FDA 510(k) clearance on 2017-05-30. The listed applicant is Amcad Biomed Corporation. The 510(k) number is K162574.

When did AmCAD-US receive FDA 510(k) clearance?

AmCAD-US received FDA 510(k) clearance on 2017-05-30, under 510(k) number K162574.

Who is the listed applicant for AmCAD-US?

The FDA 510(k) record lists Amcad Biomed Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AmCAD-US?

The FDA product code for AmCAD-US is LLZ.

Other records listing Amcad Biomed Corporation as applicant

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.

K203555AmCAD-UT K180867AmCAD-UO K180006AmCAD-UT Detection 2.2 K170069AmCAD-UV

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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.