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510(k) Data Aggregation

    K Number
    K970087
    Device Name
    CR PERFECT
    Date Cleared
    1997-03-06

    (55 days)

    Product Code
    Regulation Number
    862.1225
    Why did this record match?
    Applicant Name (Manufacturer) :

    **CHIMERA RESEARCH **& CHEMICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K954514
    Device Name
    UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE
    Date Cleared
    1996-06-21

    (267 days)

    Product Code
    Regulation Number
    862.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    **CHIMERA RESEARCH **& CHEMICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K951877
    Device Name
    AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE
    Date Cleared
    1996-05-14

    (403 days)

    Product Code
    Regulation Number
    862.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    **CHIMERA RESEARCH **& CHEMICAL, INC

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

    Ask a specific question about this device

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