Product code LBR
- Device name
- Ldl & Vldl Precipitation, Hdl
- 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 |
|---|---|---|---|
| K143691 | LDLC3 LDL-Cholesterol Gen.3 | Roche Diagnostics Operations (Rdo) | 2015-01-28 |
| K072523 | DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS | General Atomics | 2008-01-22 |
| K050823 | DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR | Teco Diagnostics | 2005-07-26 |
| K023784 | RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER | Hemagen Diagnostics, Inc. | 2002-12-24 |
| K012593 | VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 | Ortho-Clinical Diagnostics, Inc. | 2001-08-30 |
| K992029 | ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS | Elan Diagnostics | 1999-08-12 |
| K992002 | AUTOHDL CHOLESTEROL REAGENT SET | Pointe Scientific, Inc., | 1999-08-05 |
| K991789 | ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS | Elan Holdings, Inc. | 1999-07-09 |
| K990247 | MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 | Polymer Technology Systems, Inc. | 1999-05-28 |
| K984303 | VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT | Ortho-Clinical Diagnostics, Inc. | 1999-01-28 |
| K980772 | HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 | Diagnostic Chemicals , Ltd. | 1998-04-27 |
| K980770 | HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 | Diagnostic Chemicals , Ltd. | 1998-04-21 |
| K974733 | BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL | Boehringer Mannheim Corp. | 1998-01-26 |
| K973369 | ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) | Roche Diagnostic Systems, Inc. | 1997-11-21 |
| K971573 | N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET | Genzyme Corp. | 1997-06-18 |
| K962723 | TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN | Trace America, Inc. | 1997-03-13 |
| K962186 | N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR | Genzyme Corp. | 1996-08-19 |
| K954179 | HDL PRECIPITATING REAGENT | Schiapparelli Biosystems, Inc. | 1995-12-11 |
| K944975 | MAGNETIC HDL CHOLESTEROL TEST | Reference Diagnostics, Inc. | 1995-08-02 |
| K941744 | PBI PLUS HDL PRECIPITATING REAGENT | Merchant House Scientific | 1994-09-06 |
| K932766 | HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) | Diagnostic Chemicals, Ltd. (Usa) | 1993-12-10 |
| K934961 | SPINPRO HDL PRECIPITATING REAGENT | Merchant House Scientific | 1993-12-09 |
| K934801 | SPINPRO HDL PRECIPITATING REAGENT | Merchant House Scientific | 1993-12-07 |
| K934039 | INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET | Intersect Systems, Inc. | 1993-11-16 |
| K931773 | HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) | King Diagnostics, Inc. | 1993-08-16 |
| K924427 | SYNERMED HDL CHOLESTLEROL REAGENT KIT | Synermed, Inc. | 1992-11-09 |
| K914811 | IL TEST(TM) HDL CHOLESTEROL | Instrumentation Laboratory CO | 1992-01-09 |
| K912823 | HIGH DENSITY LIPOPROTEIN CHOLESTEROL | Creative Laboratory Products, Inc. | 1991-08-16 |
| K911906 | MAGNETIC HDL CHOLESTEROL TEST | Reference Diagnostics, Inc. | 1991-07-18 |
| K911406 | HDL CHOLESTEROL REAGENT | Genzyme Corp. | 1991-05-22 |
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|---|---|---|---|
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| 00381934747019 | Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus Home | POLYMER TECHNOLOGY SYSTEMS, INC. | 2023-03-25 |
| 00381934750019 | CardioChek Plus Home Self-Test Analyzer | POLYMER TECHNOLOGY SYSTEMS, INC. | 2022-04-11 |
| 14987481164533 | L-Type LDL-C Reagent 1 | FUJIFILM WAKO PURE CHEMICAL CORPORATION | 2021-06-01 |
| 14987481164540 | L-Type LDL-C Reagent 2 | FUJIFILM WAKO PURE CHEMICAL CORPORATION | 2021-06-01 |
| 00381934722016 | CardioChek Plus Home Lipid Panel Self-Test Strip 2ct | POLYMER TECHNOLOGY SYSTEMS, INC. | 2021-02-08 |
| 00381934721019 | CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ct | POLYMER TECHNOLOGY SYSTEMS, INC. | 2021-02-08 |
| 00381934720012 | CardioChek Plus Home Self-Test Analyzer | POLYMER TECHNOLOGY SYSTEMS, INC. | 2021-02-08 |
| 14987481164588 | L-Type HDL-C Reagent 1 | FUJIFILM WAKO PURE CHEMICAL CORPORATION | 2020-10-23 |
| 14987481164595 | L-Type HDL-C Reagent 2 | FUJIFILM WAKO PURE CHEMICAL CORPORATION | 2020-10-23 |
| 08809319396512 | CURO L7 Lipid Test Strip - Lipid Profile | SD Biosensor, Inc. | 2020-04-21 |
| 08809319396161 | CURO L7 Analyzer | SD Biosensor, Inc. | 2020-04-21 |
| 00381932477017 | PTS Panels® CHOL+HDL+GLU Test Strips (10-ct) + MeMoChip | POLYMER TECHNOLOGY SYSTEMS, INC. | 2019-10-15 |
| 00381932478014 | CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk) | POLYMER TECHNOLOGY SYSTEMS, INC. | 2019-10-15 |
| 00381932470018 | PTS Panels® Lipid Panel Test Strips (10-ct) | POLYMER TECHNOLOGY SYSTEMS, INC. | 2019-10-15 |
| 00381932469012 | PTS Panels® CHOL+HDL+GLU Test Strips (10-ct) | POLYMER TECHNOLOGY SYSTEMS, INC. | 2019-10-15 |
| 10763924550507 | LipidPlus® Meter | JANT PHARMACAL CORPORATION | 2017-02-16 |
| 00304040040539 | CardioChek | HENRY SCHEIN, INC. | 2017-01-16 |
| 00304040037713 | CardioChek | HENRY SCHEIN, INC. | 2017-01-05 |
| 10304040037734 | CardioChek | HENRY SCHEIN, INC. | 2017-01-05 |
| 00380740000356 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00381932400015 | PTS Panels Metabolic ChemistryTest Strips (15-ct) | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |
| 00381932412018 | PTS Panels® CHOL+HDL+GLU Test Strips | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |
| 00381931782013 | CardioChek® Analyzer; Refurbished | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |
| 00381931757011 | CardioChek® PA Professional Analyzer, Refurbished | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |
| 00381930860019 | ChekMate™ Strips | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |
| 00381931710016 | PTS Panels® Lipid Panel Test Strips | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |
| 00381932701013 | CardioChek® Plus Professional Analyzer | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |
| 00381932729017 | CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk) | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |
| 00381931708013 | CardioChek® PA analyzer | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |