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510(k) Data Aggregation

    K Number
    K960392
    Device Name
    CDM
    Manufacturer
    BIO-RAD
    Date Cleared
    1996-07-08

    (161 days)

    Product Code
    LDM, CDK, CHQ, LAA, LFI
    Regulation Number
    862.2260
    Why did this record match?
    Product Code :

    LDM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A software package and instrument interface that is used for quantitative analyses of high performance liquid chromatography (HPLC) test kits.
    Device Description
    The CDM makes use of a 486 IBM compatible computer and a separate communications interface. The system accepts signals from a detector, integrates the chromatograms, identifies reference peaks and performs calculations of percent area. In addition, the CDM can control pumps and an automated sampler and store quality control data.
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    K Number
    K961557
    Device Name
    ALLIANCE 2690 SEPARATIONS MODULE
    Manufacturer
    WATERS CORPORATION
    Date Cleared
    1996-07-05

    (74 days)

    Product Code
    LDM
    Regulation Number
    862.2260
    Why did this record match?
    Product Code :

    LDM

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