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

    VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)

    K Number: K990618 · Decision Jul 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    12
    Applicant Total
    48
    Review Days
    148

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    Basic Information

    Device Name
    VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
    K Number
    K990618
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ventana Medical Systems, Inc.
    Date Received
    February 25, 1999
    Decision Date
    July 23, 1999
    Product Code
    MXZ
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor

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    Other Clearances by Ventana Medical Systems, Inc.

    K Number Device Name
    K242783 Roche Digital Pathology Dx
    DEN240025 VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
    K232879 Roche Digital Pathology Dx (VENTANA DP 200)
    K212176 CINtec Histology
    K172471 VENTANA CD30 (Ber-H2) RxDx Assay
    DEN160019 CINtec Histology (50 tests), CINtec Histology (250 tests)
    K142965 Virtuoso System for IHC PR (1E2) using iScan HT
    K140465 VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
    K130515 VIRTUOSO SYSTEM FOR IHC ER (SPI)
    K121516 VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
    Search all 48 clearances from Ventana Medical Systems, Inc. →