Total Cholesterol Reagent Set
FDA 510(k) K820950 · Sterling Biochemical, Inc.
510(k) numberK820950
Submission
- Device name
- Total Cholesterol Reagent Set
- Applicant
- Sterling Biochemical, Inc.
Mchenry, IL, US - Received
- April 6, 1982
- Decision date
- April 26, 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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| 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 |
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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 |
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|---|---|---|
| K844998 | Glucose(Hexokinase) Reagent SetCFR · Traditional | 01/18/1985SE |
| K844251 | Alt/Gpt Reagent SetCKA · Traditional | 01/08/1985SE |
| K843332 | Alkaline Phosphatase Reagent SetCJE · Traditional | 09/14/1984SE |
| K842521 | Ast/Got Reagent Set UV RateCIT · Traditional | 08/12/1984SE |
| K840064 | Urea Nitrogen Reagent SetCDQ · Traditional | 06/14/1984SE |
| K834084 | Hydroxybutyrate Dehydrogenase ReagentJKF · Traditional | 02/04/1984SE |
| K834045 | Uric Acid Reagent SetKNK · Traditional | 01/30/1984SE |
| K833864 | Amylase Reagent Set-Modified CarawayCJA · Traditional | 01/13/1984SE |
| K833062 | Serum Cholinesterase Reagent SetDLI · Traditional | 11/25/1983SE |
| K831874 | Lipase Reagent SetJGX · Traditional | 08/12/1983SE |
Questions and answers
When was Total Cholesterol Reagent Set cleared by the FDA?
Total Cholesterol Reagent Set (K820950) received a 510(k) decision of Substantially Equivalent on April 26, 1982, 20 days after the submission was received.
What is the product code of K820950?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.