HDL Reagent Set for Lipoproteins
FDA 510(k) K780389 · Worthington Biochemical Corp.
510(k) numberK780389
Submission
- Device name
- HDL Reagent Set for Lipoproteins
- Applicant
- Worthington Biochemical Corp.
Mchenry, IL, US - Received
- March 10, 1978
- Decision date
- April 19, 1978
- 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 |
|---|---|---|
| K780096 | LDH Isoenzyme Control SerumJJY · Traditional | 03/03/1978SE |
| K772356 | LDH Isoenzyme Column Reagent SetCEX · Traditional | 01/24/1978SE |
| K772025 | Uric Acid Std. for Quant. Uric AcidJIS · Traditional | 11/11/1977SE |
| K771143 | Inorganic Phosphorus StandardsJIT · Traditional | 07/11/1977SE |
| K771001 | Statzyme GlucoseCGA · Traditional | 07/11/1977SE |
| K770831 | Statzyme Uric Acid ReagentCDO · Traditional | 07/11/1977SE |
| K770470 | Worthington BunCDW · Traditional | 06/02/1977SE |
| K770277 | Cholesterol StandardsJIT · Traditional | 03/01/1977SE |
| K761263 | Cholesterol Automated ReagentCHH · Traditional | 12/29/1976SE |
| K761262 | Triglycerides (Lipase) Reagent SetCDT · Traditional | 12/29/1976SE |
Questions and answers
When was HDL Reagent Set for Lipoproteins cleared by the FDA?
HDL Reagent Set for Lipoproteins (K780389) received a 510(k) decision of Substantially Equivalent on April 19, 1978, 40 days after the submission was received.
What is the product code of K780389?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.