MRR — System, Test, Low Density, Lipoprotein Class I

FDA Device Classification

Classification Details

Product Code
MRR
Device Class
Class I
Regulation Number
862.1475
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241800siemens healthcare diagnosticsAtellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)July 26, 2024
K210801numaresAXINON® LDL-p Test SystemJuly 19, 2023
K161691randox laboratories limitedDirect LDL Cholesterol (LDL)March 20, 2017
K091333alfa wassermannS-TEST LDL CHOLESTEROL (LDL), MODEL RC0022August 3, 2009
K090734medicaEASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLJuly 17, 2009
K063841liposcienceNMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLSJuly 23, 2008
K051121teco diagnosticsDIRECT LDL CHOLESTEROL, MODEL L530-60HAugust 8, 2005
K043264denka seiken coLDL-EX SEIKEN ASSAY KITJanuary 26, 2005
K041927diagnostic chemicalsLDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40November 23, 2004
K041720ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PAugust 25, 2004
K040693polymer technology systemsPTS PANELS LDL CHOLESTEROL TEST STRIPSJuly 6, 2004
K022772hemagen diagnosticsRAICHEM LDL-CHOLESTEROL DIRECT REAGENTSeptember 17, 2002
K020724dade behringDIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131May 9, 2002
K020575elan diagnosticsATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITSApril 12, 2002
K014103beckman coulterSYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATORJanuary 28, 2002
K012287roche diagnosticsMODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATIONAugust 7, 2001
K993741sigma diagnosticsEZ LDL CHOLESTEROL TEST SYSTEMJuly 3, 2000
K992766genzymeN-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GOctober 18, 1999
K991733schiapparelli biosystemsACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLSJuly 13, 1999
K984107reference diagnosticsRDI DIRECT LDL CHOLESTEROL TESTJanuary 28, 1999