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

    CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM

    K Number: K884227 · Decision Dec 9, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    301
    Applicant Total
    13
    Review Days
    64

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    Basic Information

    Device Name
    CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM
    K Number
    K884227
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    A-Kem, Inc.
    Date Received
    October 6, 1988
    Decision Date
    December 9, 1988
    Product Code
    JIX
    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
    JIX Calibrator, Multi-Analyte Mixture

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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
    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
    K873130 WASH SOLUTION KIT
    Search all 13 clearances from A-Kem, Inc. →