Cholesterol Enzymatic Endpoint
FDA 510(k) K923504 · Randox Laboratories, Ltd.
510(k) numberK923504
Submission
- Device name
- Cholesterol Enzymatic Endpoint
- Applicant
- Randox Laboratories, Ltd.
Antrim, N. Ireland, IR - Received
- July 15, 1992
- Decision date
- January 10, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Enzymatic Endpoint cleared by the FDA?
Cholesterol Enzymatic Endpoint (K923504) received a 510(k) decision of Substantially Equivalent on January 10, 1994, 544 days after the submission was received.
What is the product code of K923504?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.