Cholesterol Reagent

FDA 510(k) K971072 · Derma Media Lab., Inc.

Substantially Equivalent

510(k) numberK971072

Submission

Device name
Cholesterol Reagent
Applicant
Derma Media Lab., Inc.
Santa Fe Springs, CA, US
Received
March 24, 1997
Decision date
June 20, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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More from Axis-Shield Poc AS

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K970867Uric Acid ReagentKNK · Traditional 04/21/1997SE
K964915MagnesiumJGJ · Traditional 03/26/1997SE
K964913Iron ReagentJIY · Traditional 02/20/1997SE
K965134Alt/SgptCKA · Traditional 02/18/1997SE
K964914Alkaline PhosphataseCJE · Traditional 02/04/1997SE
K965126Ast/SgotCIT · Traditional 01/17/1997SE
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Questions and answers

When was Cholesterol Reagent cleared by the FDA?

Cholesterol Reagent (K971072) received a 510(k) decision of Substantially Equivalent on June 20, 1997, 88 days after the submission was received.

What is the product code of K971072?

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