FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K974733 |
BOEHRINGER MANNHEIM CORP. |
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL |
01/26/1998 |
K980770 |
DIAGNOSTIC CHEMICALS LTD. |
HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 |
04/21/1998 |
K980772 |
DIAGNOSTIC CHEMICALS LTD. |
HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 |
04/27/1998 |
K992029 |
ELAN DIAGNOSTICS |
ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS |
08/12/1999 |
K991789 |
ELAN HOLDINGS, INC. |
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS |
07/09/1999 |
K072523 |
GENERAL ATOMICS |
DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS |
01/22/2008 |
K962186 |
GENZYME CORP. |
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR |
08/19/1996 |
K971573 |
GENZYME CORP. |
N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET |
06/18/1997 |
K023784 |
HEMAGEN DIAGNOSTICS, INC. |
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER |
12/24/2002 |
K984303 |
Ortho-Clinical Diagnostics, Inc. |
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT |
01/28/1999 |
K012593 |
Ortho-Clinical Diagnostics, Inc. |
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 |
08/30/2001 |
K992002 |
POINTE SCIENTIFIC, INC. |
AUTOHDL CHOLESTEROL REAGENT SET |
08/05/1999 |
K990247 |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 |
05/28/1999 |
K973369 |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) |
11/21/1997 |
K143691 |
Roche Diagnostics Operations (RDO) |
LDLC3 LDL-Cholesterol Gen.3 |
01/28/2015 |
K050823 |
TECO DIAGNOSTICS |
DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR |
07/26/2005 |
K962723 |
TRACE AMERICA, INC. |
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN |
03/13/1997 |