Cholesterol Determination
FDA 510(k) K811760 · Biorent Diagnostic, Inc.
510(k) numberK811760
Submission
- Device name
- Cholesterol Determination
- Applicant
- Biorent Diagnostic, Inc.
Mchenry, IL, US - Received
- June 22, 1981
- Decision date
- July 10, 1981
- 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 |
More from Axis-Shield Poc AS
| 510(k) | Device | Decision |
|---|---|---|
| K832747 | Albumin Reagent SetCIX · Traditional | 10/14/1983SE |
| K823211 | Ck-Uv ReagentJHS · Traditional | 11/22/1982SE |
| K823060 | Hemoglobin ReagentKHG · Traditional | 11/22/1982SE |
| K822494 | Optimized Uv-Gpt Reagent SetCKA · Traditional | 09/21/1982SE |
| K822493 | Optimized Uv-Got Reagent SetCIT · Traditional | 09/21/1982SE |
| K822492 | Optimized Uv-Ldh Reagent SetCFJ · Traditional | 09/17/1982SE |
| K820768 | Colorimetric LDH Reagent SetCFH · Traditional | 04/14/1982SE |
| K820632 | Colorimetric Uric Acid Reagent SetKNK · Traditional | 03/25/1982SE |
| K813555 | Glucose Enzyme-Color Reagent SetCGA · Traditional | 01/18/1982SE |
| K813244 | UV Uric Acid DeterminationCDO · Traditional | 12/08/1981SE |
Questions and answers
When was Cholesterol Determination cleared by the FDA?
Cholesterol Determination (K811760) received a 510(k) decision of Substantially Equivalent on July 10, 1981, 18 days after the submission was received.
What is the product code of K811760?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.