Cholesterol

FDA 510(k) K863927 · Tech-Co, Inc.

Substantially Equivalent

510(k) numberK863927

Submission

Device name
Cholesterol
Applicant
Tech-Co, Inc.
Troy, MI, US
Received
October 8, 1986
Decision date
November 24, 1986
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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K180504Mission Lipid Panel Monitoring SystemCHH · Special ACON Laboratories, Inc.03/28/2018SE
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K150654CholesterolCHH · Traditional Randox Laboratories, Ltd.09/29/2015SE
K132031Afinion Lipid Panel and Afinion Lipid Panel ControlCHH · Traditional Axis-Shield Poc AS03/21/2014SE

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K901561Iron/Total Iron Binding CapacityJIY · Traditional 05/17/1990SE
K883387Alanine Amino Transferase (Colorimetric Method)CKD · Traditional 10/13/1988SE
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K883386ChlorideCHJ · Traditional 10/06/1988SE
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Questions and answers

When was Cholesterol cleared by the FDA?

Cholesterol (K863927) received a 510(k) decision of Substantially Equivalent on November 24, 1986, 47 days after the submission was received.

What is the product code of K863927?

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