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510(k) K023784

Device
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
Applicant
HEMAGEN DIAGNOSTICS, INC.
510(k) number
K023784
Product code
LBR  
Decision
Substantially Equivalent (SESE)
Decision date
2002-12-24
Date received
2002-11-12
Regulation
862.1475
Classification name
Ldl & Vldl Precipitation, Hdl
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOSE A MONTANEZ
Address
9033 Red Branch Rd. Columbia MD US 21045 21045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LBR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K143691LDLC3 LDL-Cholesterol Gen.3Roche Diagnostics Operations (Rdo)2015-01-28
K072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSGeneral Atomics2008-01-22
K050823DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATORTeco Diagnostics2005-07-26
K012593VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2Ortho-Clinical Diagnostics, Inc.2001-08-30
K992029ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSElan Diagnostics1999-08-12
K992002AUTOHDL CHOLESTEROL REAGENT SETPointe Scientific, Inc.,1999-08-05
K991789ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSElan Holdings, Inc.1999-07-09
K990247MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470Polymer Technology Systems, Inc.1999-05-28
K984303VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENTOrtho-Clinical Diagnostics, Inc.1999-01-28
K980772HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51Diagnostic Chemicals , Ltd.1998-04-27
K980770HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51Diagnostic Chemicals , Ltd.1998-04-21
K974733BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROLBoehringer Mannheim Corp.1998-01-26
K973369ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)Roche Diagnostic Systems, Inc.1997-11-21
K971573N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SETGenzyme Corp.1997-06-18
K962723TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGENTrace America, Inc.1997-03-13

Legacy Summary#

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FDA Review#

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