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

    HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G

    K Number: K000238 · Decision Apr 14, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    37
    Applicant Total
    7
    Review Days
    78

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    Basic Information

    Device Name
    HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
    K Number
    K000238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mrl Diagnostics
    Date Received
    January 27, 2000
    Decision Date
    April 14, 2000
    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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    Other Clearances by Mrl Diagnostics

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