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

    AMYLASE REAGENT KIT FOR ASTRA SYSTEMS

    K Number: K884226 · Decision Dec 9, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    9
    Applicant Total
    13
    Review Days
    64

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    Basic Information

    Device Name
    AMYLASE REAGENT KIT FOR ASTRA SYSTEMS
    K Number
    K884226
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    A-Kem, Inc.
    Date Received
    October 6, 1988
    Decision Date
    December 9, 1988
    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 A-Kem, Inc.

    K Number Device Name
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    K884227 CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM
    K882587 A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM
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    K873128 GLUCOSE REAGENT KIT
    K873129 CARBON DIOXIDE REAGENT KIT
    K873127 CHLORIDE REAGENT KIT
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