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

    EBV VCA ANTIBODY (IGM)

    K Number: K896594 · Decision Jan 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    33
    Review Days
    56

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EBV VCA ANTIBODY (IGM)
    K Number
    K896594
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Hillcrest Biologicals
    Date Received
    November 21, 1989
    Decision Date
    January 16, 1990
    Product Code
    LJN
    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
    LJN Antibody Igm, If, Epstein-Barr Virus

    Similar 510(k) Clearances

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

    BIOPLEX 2200 EBV IGM KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MODIFICATION TO SERAQUEST VCA IGM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SERAQUEST EB VAC IGM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    COPALIS EBV-M ANTIBODY ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by Hillcrest Biologicals

    K Number Device Name
    K913618 ARBOVIRUS IGM IFA TEST
    K913617 ARBOVIRUS IGG IFA TEST
    K913906 Q FEVER IGG IFA TEST
    K922374 Q FEVER IGM IFA TEST
    K900206 LYME DISEASE IGM ELISA
    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 →