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

    INCSTAR HSZ I/II IGG ELISA ASSAY

    K Number: K955363 · Decision Jul 24, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    58
    Review Days
    245

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    Basic Information

    Device Name
    INCSTAR HSZ I/II IGG ELISA ASSAY
    K Number
    K955363
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.4010
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Incstar Corp.
    Date Received
    November 22, 1995
    Decision Date
    July 24, 1996
    Product Code
    IGC
    Advisory Committee
    Pathology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IGC Formalin-Saline

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    Other Clearances by Incstar Corp.

    K Number Device Name
    K963289 INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY
    K963296 INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)
    K963297 INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)
    K960367 INCSTAR RUBELLA IGG ELISA ASSAY
    K960358 INCSTAR RUBELLA IGG FAST ELISA ASSAY
    K960434 INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
    K953567 INCSTAR 25-HYDROXYVITMIN D 1251 RIA
    K955362 INCSTAR HSV I/II IGG FAST ELISA ASSAY
    K955361 INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
    K955360 INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY
    Search all 58 clearances from Incstar Corp. →