Enzymatic Cholesterol Reagent (Single Vial)
FDA 510(k) K860717 · Trace Scientific , Ltd.
510(k) numberK860717
Submission
- Device name
- Enzymatic Cholesterol Reagent (Single Vial)
- Applicant
- Trace Scientific , Ltd.
Clayton, Vic 3168, AU - Received
- February 26, 1986
- Decision date
- April 11, 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K982121 | Enzymatic Mitochondrial Antibody (M2) ReagentDBM · Traditional | 09/17/1998SE |
| K981123 | UreaCDQ · Traditional | 04/24/1998SE |
| K962890 | Cholesterol-Incorporating Dynamic Stab Tech (DST)CHH · Traditional | 09/27/1996SE |
| K961114 | Ast Incorporating DSTCIT · Traditional | 05/23/1996SE |
| K961123 | Alt Incorporating DSTCKA · Traditional | 04/25/1996SE |
| K952488 | Trace Cobas Mira RangeCIX · Traditional | 10/13/1995SE |
| K932713 | Trace Transferrin ReagentDDQ · Traditional | 09/30/1993SE |
| K923322 | Trace Albumin-Mr ReagentCIX · Traditional | 09/11/1992SE |
| K914731 | Trace Gamma Gt-Ss ReagentJQB · Traditional | 11/19/1991SE |
| K911866 | Trace Total/Direct Bilirubin ReagentCIG · Traditional | 07/17/1991SE |
Questions and answers
When was Enzymatic Cholesterol Reagent (Single Vial) cleared by the FDA?
Enzymatic Cholesterol Reagent (Single Vial) (K860717) received a 510(k) decision of Substantially Equivalent on April 11, 1986, 44 days after the submission was received.
What is the product code of K860717?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.