AmCAD-UT Detection 2.2
K-Number: K180006 · 2018-08-31
ApplicantAmcad Biomed Corporation
Decision Date2018-08-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
AmCAD-UT Detection 2.2 is a medical device manufactured by Amcad Biomed Corporation. It received FDA 510(k) clearance on 2018-08-31 under approval number K180006. 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 2.2?
AmCAD-UT Detection 2.2 is a medical device that received FDA 510(k) clearance on 2018-08-31. It is manufactured by Amcad Biomed Corporation. The 510(k) number is K180006.
When was AmCAD-UT Detection 2.2 approved by the FDA?
AmCAD-UT Detection 2.2 received FDA 510(k) clearance on 2018-08-31, under approval number K180006.
What company makes AmCAD-UT Detection 2.2?
AmCAD-UT Detection 2.2 is manufactured by Amcad Biomed Corporation.
What is the FDA product code for AmCAD-UT Detection 2.2?
The FDA product code for AmCAD-UT Detection 2.2 is LLZ.
Other Devices by Amcad Biomed Corporation
Related Devices (Code: LLZ)
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.