In-Vitro Test for the Determination of Cholesterol
FDA 510(k) K854179 · Clinical Data, Inc.
510(k) numberK854179
Submission
- Device name
- In-Vitro Test for the Determination of Cholesterol
- Applicant
- Clinical Data, Inc.
Boston, MA, US - Received
- October 15, 1985
- Decision date
- November 25, 1985
- 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 |
|---|---|---|
| K071706 | Envoy 500 HDL; Cholesterol Reagent Kit (Model# 55301), Calibrator Kit (Model# 55118)LBS · Traditional | 12/20/2007SE |
| K052591 | Nanopia Wide Range C-Reactive Protein (CRP) Reagent KitDCK · Traditional | 02/09/2006SE |
| K033983 | Vitalab Iron ReagentJIY · Traditional | 05/21/2004SE |
| K040631 | Vitalab Direct Bilirubin ReagentCIG · Traditional | 03/18/2004SE |
| K040534 | Vitalab Amylase ReagentJFJ · Traditional | 03/11/2004SE |
| K034000 | Vitalab Triglycerides Reagent and Vitalab CalibratorCDT · Traditional | 03/10/2004SE |
| K040508 | Vitalab Magnesium ReagentJGJ · Traditional | 03/08/2004SE |
| K040467 | Vitalab Uric Acid ReagentKNK · Traditional | 03/08/2004SE |
| K031042 | Atac Hemoglobin A1C Reagent KitLCP · Traditional | 11/03/2003SE |
| K031044 | Atac Pak Uric Acid Reagent and Atac CalibratorKNK · Traditional | 07/15/2003SE |
Questions and answers
When was In-Vitro Test for the Determination of Cholesterol cleared by the FDA?
In-Vitro Test for the Determination of Cholesterol (K854179) received a 510(k) decision of Substantially Equivalent on November 25, 1985, 41 days after the submission was received.
What is the product code of K854179?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.