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

    BUN REAGENT KIT

    K Number: K873132 · Decision Oct 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    13
    Review Days
    74

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    Basic Information

    Device Name
    BUN REAGENT KIT
    K Number
    K873132
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    A-Kem, Inc.
    Date Received
    August 10, 1987
    Decision Date
    October 23, 1987
    Product Code
    LFP
    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
    LFP Conductivity Rate, Urea Nitrogen

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    Other Clearances by A-Kem, Inc.

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    K884227 CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM
    K882587 A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM
    K882586 A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM
    K873128 GLUCOSE REAGENT KIT
    K873129 CARBON DIOXIDE REAGENT KIT
    K873127 CHLORIDE REAGENT KIT
    K873131 CREATININE REAGENT KIT
    Search all 13 clearances from A-Kem, Inc. →