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510(k) K984107

Device
RDI DIRECT LDL CHOLESTEROL TEST
Applicant
REFERENCE DIAGNOSTICS, INC.
510(k) number
K984107
Product code
MRR  
Decision
Substantially Equivalent (SESE)
Decision date
1999-01-28
Date received
1998-11-17
Regulation
862.1475
Classification name
System, Test, Low Density, Lipoprotein
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH LAWLOR
Address
23 Crosby Dr. Bedford MA US 01730 01730

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MRR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc.2024-07-26
K210801AXINON® LDL-p Test SystemNumares AG2023-07-19
K161691Direct LDL Cholesterol (LDL)Randox Laboratories Limited2017-03-20
K091333S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022Alfa Wassermann, Inc.2009-08-03
K090734EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTESMedica Corp.2009-07-17
K063841NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLSLiposcience2008-07-23
K051121DIRECT LDL CHOLESTEROL, MODEL L530-60HTeco Diagnostics2005-08-08
K043264LDL-EX SEIKEN ASSAY KITDenka Seiken Co., Ltd.2005-01-26
K041927LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40Diagnostic Chemicals , Ltd.2004-11-23
K041720VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND IIOrtho-Clinical Diagnostics, Inc.2004-08-25
K040693PTS PANELS LDL CHOLESTEROL TEST STRIPSPolymer Technology Systems, Inc.2004-07-06
K022772RAICHEM LDL-CHOLESTEROL DIRECT REAGENTHemagen Diagnostics, Inc.2002-09-17
K020724DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131Dade Behring, Inc.2002-05-09
K020575ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITSElan Diagnostics2002-04-12
K014103SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATORBeckman Coulter, Inc.2002-01-28

Legacy Summary#

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FDA Review#

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