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

    AMYLASE REAGENT #88129

    K Number: K831295 · Decision Jun 30, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    52
    Review Days
    71

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    Basic Information

    Device Name
    AMYLASE REAGENT #88129
    K Number
    K831295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hi Chem, Inc.
    Date Received
    April 20, 1983
    Decision Date
    June 30, 1983
    Product Code
    KHM
    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
    KHM Nephelometric, Amylase

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    K902673 HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND
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    K862027 LDP REAGENT CARTRIDGE (NO. 88216)
    K861893 GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)
    K861879 CK REAGENT CARTRIDGE (PRODUCT NO. 88213)
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