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

    WASH SOLUTION KIT

    K Number: K873130 · Decision Oct 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    174
    Registration Numbers
    174
    Same Product Code
    207
    Applicant Total
    13
    Review Days
    74

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    Basic Information

    Device Name
    WASH SOLUTION KIT
    K Number
    K873130
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    A-Kem, Inc.
    Date Received
    August 10, 1987
    Decision Date
    October 23, 1987
    Product Code
    JJE
    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
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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    Other Clearances by A-Kem, Inc.

    K Number Device Name
    K884224 TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS
    K884225 TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS
    K884226 AMYLASE REAGENT KIT FOR ASTRA SYSTEMS
    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. →