Raichem Ldl-Cholesterol Direct Reagent
FDA 510(k) K022772 · Hemagen Diagnostics, Inc.
510(k) numberK022772
Submission
- Device name
- Raichem Ldl-Cholesterol Direct Reagent
- Applicant
- Hemagen Diagnostics, Inc.
Columbia, MD, US - Received
- August 21, 2002
- Decision date
- September 17, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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|---|---|---|---|
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| 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 |
|---|---|---|
| K041052 | Raichem Glucose UV (Liquid)CFR · Traditional | 06/30/2004SE |
| K041051 | Raichem Bun Rate Reagent (Liquid)CDQ · Traditional | 06/30/2004SE |
| K041009 | Raichem Calcium (Ocpc) Liquid ReagentCIC · Traditional | 06/25/2004SE |
| K031101 | Raichem Assayed Control Serum Level 1 & 2JJY · Abbreviated | 06/16/2003SE |
| K023784 | Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira AnaylzerLBR · Special | 12/24/2002SE |
| K022767 | Raichem Lipid CalibratorJIX · Special | 09/03/2002SE |
| K021194 | Raichem CRP High Sensitivity Test SystemDCK · Traditional | 07/29/2002SE |
| K022049 | Modification to Raichem Calcium ReagentCJY · Special | 07/19/2002SE |
| K012668 | Raichem Glucose UV ReagentCFR · Traditional | 10/15/2001SE |
| K012649 | Raichem Bun Rate ReagentCDQ · Traditional | 10/15/2001SE |
Questions and answers
When was Raichem Ldl-Cholesterol Direct Reagent cleared by the FDA?
Raichem Ldl-Cholesterol Direct Reagent (K022772) received a 510(k) decision of Substantially Equivalent on September 17, 2002, 27 days after the submission was received.
What is the product code of K022772?
The FDA product code is MRR – System, Test, Low Density, Lipoprotein, a Class I (low risk) device regulated under 21 CFR 862.1475.