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

    SERAQUEST HSV IGG

    K Number: K963282 · Decision Jan 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    37
    Applicant Total
    25
    Review Days
    154

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    Basic Information

    Device Name
    SERAQUEST HSV IGG
    K Number
    K963282
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quest Intl., Inc.
    Date Received
    August 21, 1996
    Decision Date
    January 22, 1997
    Product Code
    LGC
    Advisory Committee
    Microbiology
    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
    LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

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