BEUDAMED
    Product Code: MRR FDA class 1 21 CFR 862.1475

    System, Test, Low Density, Lipoprotein

    Clinical Chemistry

    The Low Density Lipoprotein (LDL) Test System is a clinical chemistry in vitro diagnostic device used to measure LDL cholesterol levels in patient blood samples, supporting the assessment of cardiovascular risk and monitoring of lipid-lowering therapy. Classified as FDA Class 1 under 21 CFR 862.1475 in the Clinical Chemistry specialty, it is 510(k)-exempt and subject only to general controls. The product code is MRR.

    View on FDA
    510(k)s
    31
    FEI Numbers
    38
    Registration Numbers
    38
    Unique Applicants
    26
    Years Active
    34

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    Basic Information

    Product Code
    MRR
    Device Class
    FDA class 1
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 31 510(k) clearances via K numbers.

    K Number Device Name
    K241800 Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
    K210801 AXINON® LDL-p Test System
    K161691 Direct LDL Cholesterol (LDL)
    K091333 S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
    K090734 EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES
    K063841 NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS
    K051121 DIRECT LDL CHOLESTEROL, MODEL L530-60H
    K043264 LDL-EX SEIKEN ASSAY KIT
    K041927 LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
    K041720 VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II
    K040693 PTS PANELS LDL CHOLESTEROL TEST STRIPS
    K022772 RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
    K020724 DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
    K020575 ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS
    K014103 SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
    K012287 MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
    K993741 EZ LDL CHOLESTEROL TEST SYSTEM
    K992766 N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
    K991733 ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
    K984107 RDI DIRECT LDL CHOLESTEROL TEST
    K982848 COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
    K982271 WAKO DIRECT LDL-C
    K982529 RANDOX DIRECT LDL CHOLESTEROL
    K981303 DIRECT LDL
    K981978 AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
    K964064 RDI LIPIDIRECT MAGNETIC LDL REAGENT
    K964063 RDI LDL PRECIPITATION REAGENT
    K955904 EKTACHEM DT LDL CHOLESTEROL KIT
    K943150 DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT
    K924674 DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT
    K893740 LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES

    FEI Numbers

    This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.