AXINON® LDL-p Test System
FDA 510(k) K210801 · Numares AG
510(k) numberK210801
Submission
- Device name
- AXINON® LDL-p Test System
- Applicant
- Numares AG
Regensburg, DE - Received
- March 17, 2021
- Decision date
- July 19, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRR – System, Test, Low Density, Lipoprotein
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MRR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)MRR · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/26/2024SE |
| K161691 | Direct LDL Cholesterol (LDL)MRR · Traditional | Randox Laboratories Limited | 03/20/2017SE |
| K091333 | S-Test LDL Cholesterol (LDL), Model RC0022MRR · Traditional | Alfa Wassermann, Inc. | 08/03/2009SE |
| K090734 | Easyra DLDL Reagent, Calibrator; Easyqc Chemistry No Electrolytes, with ElectrolytesMRR · Traditional | Medica Corp. | 07/17/2009SE |
| K063841 | NMR Profiler and NMR Lipoprofile Assay, ControlsMRR · Traditional | Liposcience | 07/23/2008SE |
| K051121 | Direct LDL Cholesterol, Model L530-60HMRR · Traditional | Teco Diagnostics | 08/08/2005SE |
| K043264 | Ldl-Ex Seiken Assay KitMRR · Traditional | Denka Seiken Co., Ltd. | 01/26/2005SE |
| K041927 | Ldl/Advance Assay, Cat. No. 279-20, 279-40MRR · Traditional | Diagnostic Chemicals , Ltd. | 11/23/2004SE |
| K041720 | Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and…MRR · Traditional | Ortho-Clinical Diagnostics, Inc. | 08/25/2004SE |
| K040693 | PTS Panels LDL Cholesterol Test StripsMRR · Traditional | Polymer Technology Systems, Inc. | 07/06/2004SE |
Questions and answers
When was AXINON® LDL-p Test System cleared by the FDA?
AXINON® LDL-p Test System (K210801) received a 510(k) decision of Substantially Equivalent on July 19, 2023, 854 days after the submission was received.
What is the product code of K210801?
The FDA product code is MRR – System, Test, Low Density, Lipoprotein, a Class I (low risk) device regulated under 21 CFR 862.1475.