BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    INDX DIP S TICKS

    K Number: K901597 · Decision Dec 21, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    3
    Applicant Total
    5
    Review Days
    260

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    Basic Information

    Device Name
    INDX DIP S TICKS
    K Number
    K901597
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3500
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Intercare Diagnostics, Inc.
    Date Received
    April 5, 1990
    Decision Date
    December 21, 1990
    Product Code
    LSQ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LSQ Reagent, Rickettsia Serological

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LSQ), ordered by most recent decision date.

    INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)

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    FDA Class 1 ·Microbiology

    INDXTM DIP-S-TICKSTM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    LATEX R. CONORII

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    FDA Class 1 ·Microbiology
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    Other Clearances by Intercare Diagnostics, Inc.

    K Number Device Name
    K941938 THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE
    K920569 INDXTM DIP-S-TICKSTM
    K893895 HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL
    K862948 CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)