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

    ARBOVIRUS IGM IFA TEST

    K Number: K913618 · Decision Dec 3, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    33
    Review Days
    478

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    Basic Information

    Device Name
    ARBOVIRUS IGM IFA TEST
    K Number
    K913618
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3240
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hillcrest Biologicals
    Date Received
    August 13, 1991
    Decision Date
    December 3, 1992
    Product Code
    GQC
    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
    GQC Antisera, Cf, Equine Encephalitis Virus, Eee, Wee

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GQC), ordered by most recent decision date.

    ARBOVIRUS IGG IFA TEST

    FDA 510(k)
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    Other Clearances by Hillcrest Biologicals

    K Number Device Name
    K913617 ARBOVIRUS IGG IFA TEST
    K913906 Q FEVER IGG IFA TEST
    K922374 Q FEVER IGM IFA TEST
    K900206 LYME DISEASE IGM ELISA
    K896594 EBV VCA ANTIBODY (IGM)
    K884829 EBV EARLY ANTIGEN (R+D)
    K883767 LYME DISEASE IFA (IGM)
    K884591 EBV-VCA ANTIBODY (IGG)
    K883487 LYME DISEASE IFA (IGG)
    K875170 EBNA ANTIBODY
    Search all 33 clearances from Hillcrest Biologicals →