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510(k) Data Aggregation

    K Number
    K971508
    Device Name
    RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE
    Manufacturer
    BIO-WHITTAKER, INC., A CAMBREX CO.
    Date Cleared
    1997-09-17

    (145 days)

    Product Code
    KIR
    Regulation Number
    864.2280
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-WHITTAKER, INC., A CAMBREX CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RHMK II is intended for use in the isolation and identification of virus from clinical specimens from patients having a viral infection.
    Device Description
    RhMK II, (Expanded Primary Rhesus Monkey Kidney Cell Culture)
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    K Number
    K944867
    Device Name
    TOXOSTAT
    Manufacturer
    BIO-WHITTAKER, INC., A CAMBREX CO.
    Date Cleared
    1996-05-14

    (595 days)

    Product Code
    LGD
    Regulation Number
    866.3780
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-WHITTAKER, INC., A CAMBREX CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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