Ysi Models 23C & 23CM HDL & Total Choles
FDA 510(k) K801285 · Yellow Springs Instrument Co., Inc.
510(k) numberK801285
Submission
- Device name
- Ysi Models 23C & 23CM HDL & Total Choles
- Applicant
- Yellow Springs Instrument Co., Inc.
Mchenry, IL, US - Received
- May 29, 1980
- Decision date
- July 28, 1980
- 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 |
|---|---|---|
| K962070 | Ysi 400 Series Atuoclavable Reusable Temperature ProbeFLL · Traditional | 07/19/1996SE |
| K922821 | Ysi Models 4700 Foley Catheter Temperature ProbesEZL · Traditional | 11/23/1992SE |
| K922007 | Ysi Model 441A Airway Temperature ProbeBZT · Traditional | 11/04/1992SE |
| K910633 | Ysi Model 1500 Blood Glucose AnalyzerCGA · Traditional | 04/12/1991SE |
| K910718 | Ysi Precision 4000 ThermometerFLL · Traditional | 04/09/1991SE |
| K901131 | Ysi Model 1500 Sport L-Lactate AnalyzerKHP · Traditional | 08/27/1990SN |
| K893409 | Ysi Models 4400 & 4700 Esophageal Stethoscope TempBZT · Traditional | 07/20/1989SE |
| K891480 | Ysi Model 2300 Stat Glucose and L-Lactate AnalyzerCGA · Traditional | 05/22/1989SE |
| K883793 | Disposable Temperature Probes (Several Models)FLL · Traditional | 11/21/1988SE |
| K865012 | Ysi Model 801FMT · Traditional | 03/04/1987SE |
Questions and answers
When was Ysi Models 23C & 23CM HDL & Total Choles cleared by the FDA?
Ysi Models 23C & 23CM HDL & Total Choles (K801285) received a 510(k) decision of Substantially Equivalent on July 28, 1980, 60 days after the submission was received.
What is the product code of K801285?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.