BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HYDRAGEL CSF ISOFOCUSING KITS

    K Number: K033277 · Decision Nov 4, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    28
    Applicant Total
    12
    Review Days
    25

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    Basic Information

    Device Name
    HYDRAGEL CSF ISOFOCUSING KITS
    K Number
    K033277
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Morax
    Date Received
    October 10, 2003
    Decision Date
    November 4, 2003
    Product Code
    CFF
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)

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    Other Clearances by Morax

    K Number Device Name
    K012789 MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
    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 →