FDA 510(k)

Cholestech LDX ™ System

K-Number: K223179 · 2023-09-20

Decision Date2023-09-20

Product CodeCGA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Cholestech LDX ™ System is the device name listed in this FDA 510(k) record. The listed applicant is Alere San Diego, Inc.. It received FDA 510(k) clearance on 2023-09-20 under 510(k) 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. The listed applicant is Alere San Diego, Inc.. The 510(k) number is K223179.

When did Cholestech LDX ™ System receive FDA 510(k) clearance?

Cholestech LDX ™ System received FDA 510(k) clearance on 2023-09-20, under 510(k) number K223179.

Who is the listed applicant for Cholestech LDX ™ System?

The FDA 510(k) record lists Alere San Diego, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cholestech LDX ™ System?

The FDA product code for Cholestech LDX ™ System is CGA.

Related Devices (Code: CGA)

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.

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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.