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510(k) Data Aggregation

    K Number
    K964864
    Device Name
    PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY
    Manufacturer
    ALEXON BIOMEDICAL, INC.
    Date Cleared
    1997-02-04

    (62 days)

    Product Code
    LLH
    Regulation Number
    866.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXON BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K955157
    Device Name
    PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY
    Manufacturer
    ALEXON BIOMEDICAL, INC.
    Date Cleared
    1996-02-09

    (88 days)

    Product Code
    MHI
    Regulation Number
    866.3220
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXON BIOMEDICAL, INC.

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

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