Cholestech LDX System
K-Number: K223179 · 2023-09-20
ApplicantAlere San Diego, Inc.
Decision Date2023-09-20
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Cholestech LDX System is a medical device manufactured by Alere San Diego, Inc.. It received FDA 510(k) clearance on 2023-09-20 under approval number K223179. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cholestech LDX System?
Cholestech LDX System is a medical device that received FDA 510(k) clearance on 2023-09-20. It is manufactured by Alere San Diego, Inc.. The 510(k) number is K223179.
When was Cholestech LDX System approved by the FDA?
Cholestech LDX System received FDA 510(k) clearance on 2023-09-20, under approval number K223179.
What company makes Cholestech LDX System?
Cholestech LDX System is manufactured by Alere San Diego, Inc..
What is the FDA product code for Cholestech LDX System?
The FDA product code for Cholestech LDX System is CGA.
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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.