Atac Direct LDL Reagent and Atac Direct LDL Calibrator Kits
FDA 510(k) K020575 · Elan Diagnostics
510(k) numberK020575
Submission
- Device name
- Atac Direct LDL Reagent and Atac Direct LDL Calibrator Kits
- Applicant
- Elan Diagnostics
Brea, CA, US - Received
- February 21, 2002
- Decision date
- April 12, 2002
- 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
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| 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 |
| K210801 | AXINON® LDL-p Test SystemMRR · Traditional | Numares AG | 07/19/2023SE |
| 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 |
More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K030003 | Atac Direct Bilirubin Reagent and CalibratorCIG · Traditional | 09/29/2003SE |
| K030014 | Atac Total Bilirubin ReagentCIG · Traditional | 09/26/2003SE |
| K030621 | Atac CalibratorJIX · Traditional | 03/19/2003SE |
| K023105 | Atac Calcium Reagent and Atac CalibratorCIC · Traditional | 03/13/2003SE |
| K030010 | Atac Pak Magnesium ReagentJGJ · Traditional | 03/10/2003SE |
| K030015 | Atac Pak Phosphorus ReagentCEO · Traditional | 03/07/2003SE |
| K030006 | Atac Pak Albumin ReagentCIX · Traditional | 03/07/2003SE |
| K023407 | Atac Pak Creatinine Reagent and Atac CalibratorCGX · Traditional | 02/14/2003SE |
| K021385 | Atac Pak Bun ReagentCDQ · Traditional | 07/12/2002SE |
| K002285 | Atac Pak Alp Reagent KitCJE · Traditional | 09/26/2000SE |
Questions and answers
When was Atac Direct LDL Reagent and Atac Direct LDL Calibrator Kits cleared by the FDA?
Atac Direct LDL Reagent and Atac Direct LDL Calibrator Kits (K020575) received a 510(k) decision of Substantially Equivalent on April 12, 2002, 50 days after the submission was received.
What is the product code of K020575?
The FDA product code is MRR – System, Test, Low Density, Lipoprotein, a Class I (low risk) device regulated under 21 CFR 862.1475.