Panels › Clinical Chemistry › Product code LBR · Class 1
Ldl & Vldl Precipitation, Hdl
Regulation 862.1475
0510(k)s in 12 months (66 all time)
0recalls in 12 months (11 all time)
10recalls that name a 510(k)
Top companies in LBR
| Company | 510(k)s | Recalls |
|---|---|---|
| Pointe Scientific, Inc., | 3 | 5 |
| Diagnostic Chemicals , Ltd. | 3 | 0 |
| Genzyme Corp. | 3 | 0 |
| Merchant House Scientific | 3 | 0 |
| Stanbio Laboratory, Inc | 0 | 3 |
| American Monitor Corp. | 2 | 0 |
| Boehringer Mannheim Corp. | 2 | 0 |
| Ortho-Clinical Diagnostics, Inc. | 2 | 0 |
| Preventive Diagnostics Corp. | 2 | 0 |
| Reference Diagnostics, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 28, 2015 | K143691 | LDLC3 LDL-Cholesterol Gen.3 Roche Diagnostics Operations (Rdo) | LBR |
| Jan 22, 2008 | K072523 | DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS General Atomics | LBR |
| Jul 26, 2005 | K050823 | DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR Teco Diagnostics | LBR |
| Dec 24, 2002 | K023784 | RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER Hemagen Diagnostics, Inc. | LBR |
| Aug 30, 2001 | K012593 | VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 Ortho-Clinical Diagnostics, Inc. | LBR |
| Aug 12, 1999 | K992029 | ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS Elan Diagnostics | LBR |
| Aug 5, 1999 | K992002 | AUTOHDL CHOLESTEROL REAGENT SET Pointe Scientific, Inc., | LBR |
| Jul 9, 1999 | K991789 | ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS Elan Holdings, Inc. | LBR |
| May 28, 1999 | K990247 | MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 Polymer Technology Systems, Inc. | LBR |
| Jan 28, 1999 | K984303 | VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT Ortho-Clinical Diagnostics, Inc. | LBR |
| Apr 27, 1998 | K980772 | HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 Diagnostic Chemicals , Ltd., CA | LBR |
| Apr 21, 1998 | K980770 | HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 Diagnostic Chemicals , Ltd., CA | LBR |
| Jan 26, 1998 | K974733 | BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL Boehringer Mannheim Corp. | LBR |
| Nov 21, 1997 | K973369 | ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) Roche Diagnostic Systems, Inc. | LBR |
| Jun 18, 1997 | K971573 | N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET Genzyme Corp. | LBR |
| Mar 13, 1997 | K962723 | TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN Trace America, Inc. | LBR |
| Aug 19, 1996 | K962186 | N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR Genzyme Corp. | LBR |
| Dec 11, 1995 | K954179 | HDL PRECIPITATING REAGENT Schiapparelli Biosystems, Inc. | LBR |
| Aug 2, 1995 | K944975 | MAGNETIC HDL CHOLESTEROL TEST Reference Diagnostics, Inc. | LBR |
| Sep 6, 1994 | K941744 | PBI PLUS HDL PRECIPITATING REAGENT Merchant House Scientific | LBR |
| Dec 10, 1993 | K932766 | HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) Diagnostic Chemicals, Ltd. (Usa), CA | LBR |
| Dec 9, 1993 | K934961 | SPINPRO HDL PRECIPITATING REAGENT Merchant House Scientific | LBR |
| Dec 7, 1993 | K934801 | SPINPRO HDL PRECIPITATING REAGENT Merchant House Scientific | LBR |
| Nov 16, 1993 | K934039 | INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET Intersect Systems, Inc. | LBR |
| Aug 16, 1993 | K931773 | HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) King Diagnostics, Inc. | LBR |
| Nov 9, 1992 | K924427 | SYNERMED HDL CHOLESTLEROL REAGENT KIT Synermed, Inc., CA | LBR |
| Jan 9, 1992 | K914811 | IL TEST(TM) HDL CHOLESTEROL Instrumentation Laboratory CO | LBR |
| Aug 16, 1991 | K912823 | HIGH DENSITY LIPOPROTEIN CHOLESTEROL Creative Laboratory Products, Inc. | LBR |
| Jul 18, 1991 | K911906 | MAGNETIC HDL CHOLESTEROL TEST Reference Diagnostics, Inc. | LBR |
| May 22, 1991 | K911406 | HDL CHOLESTEROL REAGENT Genzyme Corp. | LBR |
| Jan 15, 1991 | K903733 | ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM Institute For Clinical Applications | LBR |
| Dec 11, 1990 | K905284 | HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 Amresco, Inc. | LBR |
| Nov 28, 1990 | K904184 | BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT Biotron U.S.A., Inc. | LBR |
| Aug 29, 1990 | K903094 | STAT TEST HDL/CHOLESTEROL TEST KIT Diagnostic Resources, Inc. | LBR |
| Aug 9, 1990 | K902568 | REFLOTRON HDL CHOLESTEROL TEST TABS Boehringer Mannheim Corp. | LBR |
| Jul 31, 1990 | K902174 | COULTER HDL - CHOLESTEROL REAGENT Coulter Corp. | LBR |
| Mar 9, 1990 | K900120 | ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL Roche Diagnostic Systems, Inc. | LBR |
| Nov 8, 1989 | K895381 | HDL SINGLES Trace America, Inc. | LBR |
| Jul 25, 1989 | K893966 | HDL PRECIPITATING REAGENT Diagnostic Systems | LBR |
| Apr 10, 1989 | K891117 | HDL CHOLESTEROL REAGENT Pointe Scientific, Inc., | LBR |
| Mar 8, 1989 | K890669 | STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE Norfolk Scientific, Inc. | LBR |
| Feb 17, 1989 | K890023 | HDL CHOLESTEROL REAGENT (PTA/MGCL2) Sigma Diagnostics, Inc. | LBR |
| Feb 10, 1989 | K885265 | HDL CHOLESTEROL TEST Em Diagnostic Systems, Inc. | LBR |
| Sep 13, 1988 | K883353 | IQ HDL CHOLESTEROL Bd Becton Dickinson Vacutainer Systems Preanalytic | LBR |
| Aug 15, 1988 | K882488 | CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES Canyon Diagnostics, Inc. | LBR |
| Jun 10, 1988 | K881244 | HDL CHOLESTEROL KIT Trace Scientific , Ltd., AU | LBR |
| May 27, 1988 | K881326 | HDL CHOLESTEROL PRECIPITATING PROCEDURE Data Medical Associates, Inc. | LBR |
| Feb 18, 1988 | K880176 | HDL CHOLESTEROL PRECIPITATING REAGENT Tech-Co, Inc. | LBR |
| Jan 7, 1988 | K874820 | MULTICHEM HDL PRECIPITATING REAGENT #S0914 Simmler, Inc. | LBR |
| Jun 27, 1986 | K861926 | WORTHINGTON HDL PRECIPITATING REAGENT SET Cooper Biomedical, Inc. | LBR |
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