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510(k) Data Aggregation

    K Number
    K991248
    Device Name
    PRONTO DRY
    Manufacturer
    MEDICAL INSTRUMENTS CORPORATION MIC AG
    Date Cleared
    1999-06-22

    (71 days)

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

    MEDICAL INSTRUMENTS CORPORATION MIC AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pronto Dry is intended for use for the detection of urease enzyme in gastric musocal biopsy specimens for the presumptive determination of Helicobacter pylori symptomatic adult patients. Note: for in vitro diagnostic use only.
    Device Description
    Not Found
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    K Number
    K950087
    Device Name
    LOT 440
    Manufacturer
    MEDICAL INSTRUMENTS CORPORATION MIC AG
    Date Cleared
    1996-02-06

    (392 days)

    Product Code
    FFT
    Regulation Number
    876.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL INSTRUMENTS CORPORATION MIC AG

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