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

    RAICHEM ACID PHASPHATASE REAGENT

    K Number: K831834 · Decision Aug 26, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    63
    Review Days
    80

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    Basic Information

    Device Name
    RAICHEM ACID PHASPHATASE REAGENT
    K Number
    K831834
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Reagents Applications, Inc.
    Date Received
    June 7, 1983
    Decision Date
    August 26, 1983
    Product Code
    CKB
    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
    CKB Acid Phosphatase, Naphthyl Phosphate

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