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

    IMMUCHEM PHE-MW EA

    K Number: K926106 · Decision Feb 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    14
    Applicant Total
    11
    Review Days
    797

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    Basic Information

    Device Name
    IMMUCHEM PHE-MW EA
    K Number
    K926106
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1555
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Icn Biomedicals, Inc.
    Date Received
    December 3, 1992
    Decision Date
    February 8, 1995
    Product Code
    JNB
    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
    JNB Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine

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    Other Clearances by Icn Biomedicals, Inc.

    K Number Device Name
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    K922715 IMMUCHEM PRL-MW ELISA
    K922376 ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT
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    K902445 LYMPHO SEP(TM)
    K885198 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA
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