Enzymatic Cholesterol (Colorimetric
FDA 510(k) K823784 · Analytical & Research Chemicals, Inc.
510(k) numberK823784
Submission
- Device name
- Enzymatic Cholesterol (Colorimetric
- Applicant
- Analytical & Research Chemicals, Inc.
Mchenry, IL, US - Received
- December 16, 1982
- Decision date
- January 14, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K203597 | Cholesterol2CHH · Traditional | Abbott Ireland Diagnostics Division | 06/30/2022SE |
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| K180504 | Mission Lipid Panel Monitoring SystemCHH · Special | ACON Laboratories, Inc. | 03/28/2018SE |
| K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemCHH · Traditional | ACON Laboratories, Inc. | 07/11/2017SE |
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…CHH · Traditional | Polymer Technology Systems, Inc. | 12/22/2016SE |
| K150654 | CholesterolCHH · Traditional | Randox Laboratories, Ltd. | 09/29/2015SE |
| K132031 | Afinion Lipid Panel and Afinion Lipid Panel ControlCHH · Traditional | Axis-Shield Poc AS | 03/21/2014SE |
More from Axis-Shield Poc AS
| 510(k) | Device | Decision |
|---|---|---|
| K823806 | Direct Creatinine ProcedureCGX · Traditional | 01/14/1983SE |
| K823786 | Alkaline PhosphataseCJE · Traditional | 01/14/1983SE |
| K781460 | Chloride ReagentCHJ · Traditional | 10/10/1978SE |
| K781441 | BCG Albumin ReagetCIX · Traditional | 10/10/1978SE |
| K781324 | Alp TestCIO · Traditional | 08/31/1978SE |
| K781323 | LDH Procedure · Traditional | 08/31/1978SE |
| K781309 | Got Procedure · Traditional | 08/31/1978SE |
| K781308 | GlucolourCGE · Traditional | 08/31/1978SE |
| K781307 | Glucose Determ. KitCGA · Traditional | 08/31/1978SE |
| K781306 | Urea Nitrogen Test KitCDL · Traditional | 08/31/1978SE |
Questions and answers
When was Enzymatic Cholesterol (Colorimetric cleared by the FDA?
Enzymatic Cholesterol (Colorimetric (K823784) received a 510(k) decision of Substantially Equivalent on January 14, 1983, 29 days after the submission was received.
What is the product code of K823784?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.