Cholesterol-Enzymatic Reagent Set
FDA 510(k) K831863 · Stanbio Laboratory
510(k) numberK831863
Submission
- Device name
- Cholesterol-Enzymatic Reagent Set
- Applicant
- Stanbio Laboratory
Mchenry, IL, US - Received
- June 10, 1983
- Decision date
- July 22, 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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|---|---|---|---|
| K251091 | LipidsCHH · Traditional | Truvian Health | 12/30/2025SE |
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| 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 |
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| K050266 | Direct Bilirubin Liquicolor and Total Bilirubin LiquicolorJFM · Traditional | 06/30/2005SE |
| K042169 | Stanbio Laboratory Sirrus Clinical Chemistry AnalyzerJJE · Traditional | 03/14/2005SE |
| K041155 | Wide Range C-Reactive Protein (WR CRP) AssayDCK · Traditional | 10/14/2004SE |
| K032936 | Direct LDL Cholesterol Liquid Color and Stanbio Direct Hdl/Ldl Cholesterol CalibratorJIX · Traditional | 03/12/2004SE |
| K032932 | Direct Hdl-Cholesterol Liquid Color; Direct Hdl/Ldl-Cholesterol CalibratorLBS · Traditional | 03/10/2004SE |
| K032482 | Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemGKR · Traditional | 10/24/2003SE |
| K020378 | Qupid Plus E.R.JHI · Traditional | 06/21/2002SE |
Questions and answers
When was Cholesterol-Enzymatic Reagent Set cleared by the FDA?
Cholesterol-Enzymatic Reagent Set (K831863) received a 510(k) decision of Substantially Equivalent on July 22, 1983, 42 days after the submission was received.
What is the product code of K831863?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.