FDA 510(k) Applications for Medical Device Product Code "LBR"
(Ldl & Vldl Precipitation, Hdl)

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


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