Product code MRR
- Device name
- System, Test, Low Density, Lipoprotein
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1475
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) | Siemens Healthcare Diagnostics, Inc. | 2024-07-26 |
| K210801 | AXINON® LDL-p Test System | Numares AG | 2023-07-19 |
| K161691 | Direct LDL Cholesterol (LDL) | Randox Laboratories Limited | 2017-03-20 |
| K091333 | S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 | Alfa Wassermann, Inc. | 2009-08-03 |
| K090734 | EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES | Medica Corp. | 2009-07-17 |
| K063841 | NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS | Liposcience | 2008-07-23 |
| K051121 | DIRECT LDL CHOLESTEROL, MODEL L530-60H | Teco Diagnostics | 2005-08-08 |
| K043264 | LDL-EX SEIKEN ASSAY KIT | Denka Seiken Co., Ltd. | 2005-01-26 |
| K041927 | LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 | Diagnostic Chemicals , Ltd. | 2004-11-23 |
| K041720 | VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II | Ortho-Clinical Diagnostics, Inc. | 2004-08-25 |
| K040693 | PTS PANELS LDL CHOLESTEROL TEST STRIPS | Polymer Technology Systems, Inc. | 2004-07-06 |
| K022772 | RAICHEM LDL-CHOLESTEROL DIRECT REAGENT | Hemagen Diagnostics, Inc. | 2002-09-17 |
| K020724 | DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 | Dade Behring, Inc. | 2002-05-09 |
| K020575 | ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS | Elan Diagnostics | 2002-04-12 |
| K014103 | SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR | Beckman Coulter, Inc. | 2002-01-28 |
| K012287 | MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION | Roche Diagnostics Corp. | 2001-08-07 |
| K993741 | EZ LDL CHOLESTEROL TEST SYSTEM | Sigma Diagnostics, Inc. | 2000-07-03 |
| K992766 | N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET | Genzyme Corp. | 1999-10-18 |
| K991733 | ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS | Schiapparelli Biosystems, Inc. | 1999-07-13 |
| K984107 | RDI DIRECT LDL CHOLESTEROL TEST | Reference Diagnostics, Inc. | 1999-01-28 |
| K982848 | COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT | Roche Diagnostic Systems, Inc. | 1998-10-01 |
| K982271 | WAKO DIRECT LDL-C | Wako Chemicals USA, Inc. | 1998-09-22 |
| K982529 | RANDOX DIRECT LDL CHOLESTEROL | Randox Laboratories, Ltd. | 1998-09-11 |
| K981303 | DIRECT LDL | Abbott Laboratories | 1998-08-03 |
| K981978 | AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR | Pointe Scientific, Inc., | 1998-07-22 |
| K964063 | RDI LDL PRECIPITATION REAGENT | Reference Diagnostics, Inc. | 1996-11-20 |
| K964064 | RDI LIPIDIRECT MAGNETIC LDL REAGENT | Reference Diagnostics, Inc. | 1996-11-20 |
| K955904 | EKTACHEM DT LDL CHOLESTEROL KIT | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-24 |
| K943150 | DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT | Genzyme Corp. | 1995-03-15 |
| K924674 | DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT | Genzyme Corp. | 1993-01-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06935740726986 | Blood Lipid Test Strip | Urit Medical Electronic Co., Ltd. | 2024-07-12 |
| 10673486002010 | Teco Diagnostics Direct LDL Cholesterol Reagent Set | TECO DIAGNOSTICS | 2023-11-13 |
| 06971674860600 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860716 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860709 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860693 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860686 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860679 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860662 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860655 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860648 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860631 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860624 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860617 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860594 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860587 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860723 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860730 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860747 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860754 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 06971674860761 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-12 |
| 05055273213966 | DIRECT LDL-CHOLESTEROL (LDL) | RANDOX LABORATORIES LIMITED | 2022-10-04 |
| 00817302024142 | CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT AU-661 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00630414611037 | Atellica CH LDLC | Siemens Healthcare Diagnostics Inc. | 2022-07-08 |
| 00386100002206 | LDL CHOL Reagent Kit | MEDICA CORPORATION | 2019-02-14 |
| 00817302022667 | CAROLINA LIQUID CHEMISTRIES CORP.® LDL DIRECT REAGENT CC667 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2018-08-27 |
| B3959930030 | NMR Reference Standard | Labcorp of America | 2017-04-18 |
| B3959920030 | NMR Diluent 1 | Labcorp of America | 2017-04-18 |
| B3959910030 | NMR WASH Solution | Labcorp of America | 2016-11-11 |
| B3959900300 | Vantera Clinical Analyzer | Labcorp of America | 2016-11-11 |