BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)

    K Number: K895555 · Decision Dec 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    9
    Applicant Total
    41
    Review Days
    107

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    Basic Information

    Device Name
    MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)
    K Number
    K895555
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hichem Diagnostics
    Date Received
    September 6, 1989
    Decision Date
    December 22, 1989
    Product Code
    CJA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CJA Amyloclastic, Amylase

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    Other Clearances by Hichem Diagnostics

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    K953860 HICHEM ISE DILUENT KIT 70008
    K953861 HICHEM ISE INTDERNAL REFERENCE KIT 70009
    K953863 HICHEM ISE STANDARDS KIT 70011
    K951751 HICHEM AST REAGENT KIT
    K946192 HICHEM Y-GT REAGENT KIT
    K946022 HICHEM LDH/L REAGENT KIT
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