Cholesterol

FDA 510(k) K150654 · Randox Laboratories, Ltd.

Substantially Equivalent

510(k) numberK150654

Submission

Device name
Cholesterol
Applicant
Randox Laboratories, Ltd.
Crumlin, GB
Received
March 13, 2015
Decision date
September 29, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CHH – Enzymatic Esterase--Oxidase, Cholesterol
Device class
Class I (low risk)
Regulation
21 CFR 862.1175
Specialty
Clinical Chemistry

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Questions and answers

When was Cholesterol cleared by the FDA?

Cholesterol (K150654) received a 510(k) decision of Substantially Equivalent on September 29, 2015, 200 days after the submission was received.

What is the product code of K150654?

The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.