Fast Cholesterol (Total Cholesterol Test)
FDA 510(k) K862507 · Sclavo, Inc.
510(k) numberK862507
Submission
- Device name
- Fast Cholesterol (Total Cholesterol Test)
- Applicant
- Sclavo, Inc.
Wayne, NJ, US - Received
- July 1, 1986
- Decision date
- July 16, 1986
- 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 |
|---|---|---|
| K914789 | Elisa CMV IgmLKQ · Traditional | 03/04/1992SE |
| K914852 | Elisa Toxo IgmLGD · Traditional | 01/23/1992SE |
| K914420 | Elisa Rubella IgmLFX · Traditional | 12/27/1991SE |
| K895943 | Normal and Abnormal Control SeraJJY · Traditional | 12/27/1989SE |
| K895822 | Total Bilirubin L.F.CIG · Traditional | 11/14/1989SE |
| K895847 | Creatinine 340 (Enzymatic)CGX · Traditional | 10/30/1989SE |
| K880199 | Cholinesterase - Acetythiocholine SubstrateDIH · Traditional | 01/27/1989SE |
| K880049 | Cholinesterase - Butyrythiocholine SubstrateDIH · Traditional | 01/27/1989SE |
| K873496 | Atypical CholinesteraseDIH · Traditional | 01/27/1989SE |
| K884035 | Saitron 430 Random Access Chemistry AnalyzerJJE · Traditional | 12/29/1988SE |
Questions and answers
When was Fast Cholesterol (Total Cholesterol Test) cleared by the FDA?
Fast Cholesterol (Total Cholesterol Test) (K862507) received a 510(k) decision of Substantially Equivalent on July 16, 1986, 15 days after the submission was received.
What is the product code of K862507?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.