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510(k) Data Aggregation

    K Number
    K964675
    Device Name
    H.PYLORI CONTROLS
    Manufacturer
    PYRAMID BIOLOGICAL CORP.
    Date Cleared
    1997-01-27

    (67 days)

    Product Code
    LYR
    Regulation Number
    866.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    PYRAMID BIOLOGICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962399
    Device Name
    HEPATITIS NEGATIVE CONTROL
    Manufacturer
    PYRAMID BIOLOGICAL CORP.
    Date Cleared
    1996-08-02

    (42 days)

    Product Code
    MJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    PYRAMID BIOLOGICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K961317
    Device Name
    SYPHILIS IGM HUMAN SERUM CONTROLS
    Manufacturer
    PYRAMID BIOLOGICAL CORP.
    Date Cleared
    1996-06-24

    (80 days)

    Product Code
    LIP
    Regulation Number
    866.3830
    Why did this record match?
    Applicant Name (Manufacturer) :

    PYRAMID BIOLOGICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960493
    Device Name
    SYPHILIS IGG HUMAN SERUM CONTROLS
    Manufacturer
    PYRAMID BIOLOGICAL CORP.
    Date Cleared
    1996-06-17

    (137 days)

    Product Code
    LIP
    Regulation Number
    866.3830
    Why did this record match?
    Applicant Name (Manufacturer) :

    PYRAMID BIOLOGICAL CORP.

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

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