Modification to: Cobas Integra Ldl-Cholesterol Plus 2ND Generation
FDA 510(k) K012287 · Roche Diagnostics Corp.
510(k) numberK012287
Submission
- Device name
- Modification to: Cobas Integra Ldl-Cholesterol Plus 2ND Generation
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- July 20, 2001
- Decision date
- August 7, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | 08/19/2026SE |
| K252323 | cobas pulse blood glucose monitoring systemPZI · Dual Track | 06/12/2026SE |
| K252431 | Elecsys CalcitoninJKR · Traditional | 04/24/2026SE |
| K252280 | Elecsys Anti-SARS-CoV-2 SQVP · Traditional | 04/13/2026SE |
| K260049 | Elecsys Anti-HBc IgMSEI · Traditional | 04/07/2026SE |
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | 04/07/2026SE |
| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
Questions and answers
When was Modification to: Cobas Integra Ldl-Cholesterol Plus 2ND Generation cleared by the FDA?
Modification to: Cobas Integra Ldl-Cholesterol Plus 2ND Generation (K012287) received a 510(k) decision of Substantially Equivalent on August 7, 2001, 18 days after the submission was received.
What is the product code of K012287?
The FDA product code is MRR – System, Test, Low Density, Lipoprotein, a Class I (low risk) device regulated under 21 CFR 862.1475.