Chol or Cholesterol

FDA 510(k) K971345 · Carolina Liquid Chemistries Corp.

Substantially Equivalent

510(k) numberK971345

Submission

Device name
Chol or Cholesterol
Applicant
Carolina Liquid Chemistries Corp.
Brea, CA, US
Received
April 10, 1997
Decision date
May 29, 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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K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)DIO · Traditional 08/15/2017SE
K133519Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries…JJE · Traditional 05/16/2014SE
K132711Carolina Liquid Chemistries HDL Cholesterol ReagentLBS · Traditional 05/08/2014SE
K972073Total Bilirubin ReagentCIG · Traditional 06/24/1997SE
K971907Calcium ReagentCIC · Traditional 06/24/1997SE
K971324Triglycerides, TG, or TrigCDT · Traditional 06/20/1997SE
K971967BunCDQ · Traditional 06/17/1997SE
K971908Crea or CreatinineCGX · Traditional 06/17/1997SE
K971467Synchron CX Systems Glucose Reagent (Glu)CFR · Traditional 06/16/1997SE

Questions and answers

When was Chol or Cholesterol cleared by the FDA?

Chol or Cholesterol (K971345) received a 510(k) decision of Substantially Equivalent on May 29, 1997, 49 days after the submission was received.

What is the product code of K971345?

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