FDA 510(k)

AmCAD-UO

K-Number: K180867 · 2018-12-28

Decision Date2018-12-28

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AmCAD-UO 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 2018-12-28 under 510(k) 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. The listed applicant is Amcad Biomed Corporation. The 510(k) number is K180867.

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

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

Who is the listed applicant for AmCAD-UO?

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-UO?

The FDA product code for AmCAD-UO 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 K180006AmCAD-UT Detection 2.2 K162574AmCAD-US 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.