BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123

    K Number: K012789 · Decision Jan 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    12
    Review Days
    150

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    Basic Information

    Device Name
    MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
    K Number
    K012789
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Morax
    Date Received
    August 20, 2001
    Decision Date
    January 17, 2002
    Product Code
    JHO
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JHO Electrophoretic Separation, Lipoproteins

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    Other Clearances by Morax

    K Number Device Name
    K033277 HYDRAGEL CSF ISOFOCUSING KITS
    K992148 HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT
    K991362 HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
    K990250 HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0
    K981048 HYDRAGEL 6 CSF KIT
    K974854 HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207
    K972591 HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT
    K972015 HYDRAGEL 7,15,30, CHOL-HDL KIT
    K963844 HYDRAGEL 15 HB A1C KIT
    K960029 HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT
    Search all 12 clearances from Morax →