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510(k) Data Aggregation

    K Number
    K964208
    Date Cleared
    1997-04-30

    (208 days)

    Product Code
    Regulation Number
    890.5525
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    R. A. FISCHER CO. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K954031
    Date Cleared
    1996-01-05

    (130 days)

    Product Code
    Regulation Number
    878.5350
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    R. A. FISCHER CO. CORP.

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

    Ask a specific question about this device

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