BEUDAMED
    Product Code: LBR FDA class 1 21 CFR 862.1475

    Ldl & Vldl Precipitation, Hdl

    Clinical Chemistry

    LDL and VLDL precipitation for HDL measurement is a clinical chemistry test method in which low-density and very-low-density lipoproteins are selectively precipitated from serum, allowing high-density lipoprotein cholesterol to be measured in the remaining supernatant. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls with no premarket notification needed. The product code is LBR, regulated under 21 CFR 862.1475, in the Clinical Chemistry specialty. No special risk flags apply.

    View on FDA
    510(k)s
    66
    FEI Numbers
    41
    Registration Numbers
    41
    Unique Applicants
    52
    Years Active
    37

    Basic Information

    Product Code
    LBR
    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

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 66 510(k) clearances via K numbers.

    K Number Device Name
    K143691 LDLC3 LDL-Cholesterol Gen.3
    K072523 DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
    K050823 DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
    K023784 RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
    K012593 VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
    K992029 ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
    K992002 AUTOHDL CHOLESTEROL REAGENT SET
    K991789 ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
    K990247 MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470
    K984303 VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
    K980772 HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51
    K980770 HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51
    K974733 BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
    K973369 ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
    K971573 N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
    K962723 TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN
    K962186 N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
    K954179 HDL PRECIPITATING REAGENT
    K944975 MAGNETIC HDL CHOLESTEROL TEST
    K941744 PBI PLUS HDL PRECIPITATING REAGENT
    K932766 HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
    K934961 SPINPRO HDL PRECIPITATING REAGENT
    K934801 SPINPRO HDL PRECIPITATING REAGENT
    K934039 INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET
    K931773 HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)
    K924427 SYNERMED HDL CHOLESTLEROL REAGENT KIT
    K914811 IL TEST(TM) HDL CHOLESTEROL
    K912823 HIGH DENSITY LIPOPROTEIN CHOLESTEROL
    K911906 MAGNETIC HDL CHOLESTEROL TEST
    K911406 HDL CHOLESTEROL REAGENT
    K903733 ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM
    K905284 HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173
    K904184 BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT
    K903094 STAT TEST HDL/CHOLESTEROL TEST KIT
    K902568 REFLOTRON HDL CHOLESTEROL TEST TABS
    K902174 COULTER HDL - CHOLESTEROL REAGENT
    K900120 ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
    K895381 HDL SINGLES
    K893966 HDL PRECIPITATING REAGENT
    K891117 HDL CHOLESTEROL REAGENT
    K890669 STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE
    K890023 HDL CHOLESTEROL REAGENT (PTA/MGCL2)
    K885265 HDL CHOLESTEROL TEST
    K883353 IQ HDL CHOLESTEROL
    K882488 CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES
    K881244 HDL CHOLESTEROL KIT
    K881326 HDL CHOLESTEROL PRECIPITATING PROCEDURE
    K880176 HDL CHOLESTEROL PRECIPITATING REAGENT
    K874820 MULTICHEM HDL PRECIPITATING REAGENT #S0914
    K861926 WORTHINGTON HDL PRECIPITATING REAGENT SET
    K852350 HDL CHOLESTEROL PRETREATMENT
    K843894 HDL PRECIPATATING REAGENT SET
    K834251 HDL CHOLESTEROL PRETREATMENT
    K833160 HDL EZ-TAB
    K833431 HDL EX-SEP PRECIPITATING REAGENT
    K830207 RAICHEM HDL-CHOLESTEROL REAGENT
    K821203 HDL PRECIPITANT REAGENT SET
    K812839 HDL CHOLESTEROL REAGENT SET
    K812574 HDL CHOLESTEROL REAGENT
    K800996 HDL REAGENT
    K792313 CHOL-HDL TEST, HIGH LIPO. CHOL TEST
    K790865 LANCER HDL SEPARATION KIT
    K790372 H-D-EL
    K790329 A-GENT-HDL REAGENT
    K781093 HDL CENTRIFIKIT
    K780542 ALFATEST

    FEI Numbers

    This FDA classification entry is associated with 41 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 41 registration numbers. Click on an entry to view related FDA registrations.