Enzymatic Cholesterol Reagent System
FDA 510(k) K820473 · American Monitor Corp.
510(k) numberK820473
Submission
- Device name
- Enzymatic Cholesterol Reagent System
- Applicant
- American Monitor Corp.
Mchenry, IL, US - Received
- February 19, 1982
- Decision date
- March 11, 1982
- 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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|---|---|---|---|
| K251091 | LipidsCHH · Traditional | Truvian Health | 12/30/2025SE |
| K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESCHH · Traditional | Medicon Hellas S.A | 08/09/2024SE |
| K203597 | Cholesterol2CHH · Traditional | Abbott Ireland Diagnostics Division | 06/30/2022SE |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL SlidesCHH · Traditional | Ortho-Clinical Diagnostics, Inc. | 03/27/2019SE |
| K181373 | Extended Lipid Panel AssayCHH · Traditional | Laboratory Corporation of America Holdings | 10/18/2018SE |
| 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 |
|---|---|---|
| K896000 | Aspartate Aminotranferase (Ast)CIT · Traditional | 01/11/1990SE |
| K895999 | PhosphorusCEO · Traditional | 01/11/1990SE |
| K896001 | Alanine Aminotransferase (Alt)CKA · Traditional | 11/13/1989SE |
| K895423 | Access Chemistry AnalyzerJJE · Traditional | 10/04/1989SE |
| K893137 | Excel (TM) Chemistry AnalyzerJJE · Traditional | 08/10/1989SE |
| K892331 | Enzymatic Urea Nitrogen Reagent SetCDQ · Traditional | 06/20/1989SE |
| K893479 | Cholesterol Reagent SetCHH · Traditional | 06/19/1989SE |
| K892002 | Neochrome(R) III GlucoseCGA · Traditional | 06/12/1989SE |
| K890312 | Gamma-GlutamyltransferaseJQB · Traditional | 03/24/1989SE |
| K890034 | Photometric Method, Iron (Non-Heme) (75JIY)JIY · Traditional | 02/03/1989SE |
Questions and answers
When was Enzymatic Cholesterol Reagent System cleared by the FDA?
Enzymatic Cholesterol Reagent System (K820473) received a 510(k) decision of Substantially Equivalent on March 11, 1982, 20 days after the submission was received.
What is the product code of K820473?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.