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

    HPL RIA KIT

    K Number: K863188 · Decision Sep 25, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    15
    Review Days
    37

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    Basic Information

    Device Name
    HPL RIA KIT
    K Number
    K863188
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1515
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Biotecx Laboratories, Inc.
    Date Received
    August 19, 1986
    Decision Date
    September 25, 1986
    Product Code
    JMX
    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
    JMX Ninhydrin, Nitrogen (Amino-Nitrogen)

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