Cholesterol
FDA 510(k) K880237 · Tech-Neal Scientific, Inc.
510(k) numberK880237
Submission
- Device name
- Cholesterol
- Applicant
- Tech-Neal Scientific, Inc.
Westmont, IL, US - Received
- January 20, 1988
- Decision date
- April 28, 1988
- 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
Other 510(k)s with product code CHH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K882256 | Magnesium Reagent SetJGJ · Traditional | 08/08/1988SE |
| K882459 | Diazo, Colorimetric BilirubinCIG · Traditional | 08/02/1988SE |
| K881239 | Gamma Glutamyl Transferase Reagent SetJPZ · Traditional | 05/31/1988SE |
| K881241 | Total Bilirubin ReagentCIG · Traditional | 05/27/1988SE |
| K881240 | Chloride Reagent SetCHJ · Traditional | 04/28/1988SE |
| K881237 | Creatine Kinase (CK) Reagent SetJHX · Traditional | 04/28/1988SE |
| K880277 | Uric Acid Reagent SetKNK · Traditional | 04/18/1988SE |
| K880845 | Calcium Reagent SetCIC · Traditional | 04/05/1988SE |
| K880844 | Albumin Reagent SetCIX · Traditional | 04/05/1988SE |
| K880843 | Creatinine Reagent Set (Kinetic)CGX · Traditional | 04/05/1988SE |
Questions and answers
When was Cholesterol cleared by the FDA?
Cholesterol (K880237) received a 510(k) decision of Substantially Equivalent on April 28, 1988, 99 days after the submission was received.
What is the product code of K880237?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.