Cholesterol Test Kit

FDA 510(k) K895951 · Elite Technology, Inc.

Substantially Equivalent

510(k) numberK895951

Submission

Device name
Cholesterol Test Kit
Applicant
Elite Technology, Inc.
Canada M9w 5p1, CA
Received
October 11, 1989
Decision date
February 16, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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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More from Axis-Shield Poc AS

510(k)DeviceDecision
K900733Protein Test for Urine and CSFCEK · Traditional 07/10/1990SE
K901001Uric Acid Test KitKNK · Traditional 05/23/1990SE
K901090Elitech Gamma GT Test KitJPZ · Traditional 03/29/1990SE
K895952Triglycerides Test KitCDT · Traditional 01/11/1990SE

Questions and answers

When was Cholesterol Test Kit cleared by the FDA?

Cholesterol Test Kit (K895951) received a 510(k) decision of Substantially Equivalent on February 16, 1990, 128 days after the submission was received.

What is the product code of K895951?

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