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

    BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT

    K Number: K954065 · Decision Jul 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    4
    Review Days
    315

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    Basic Information

    Device Name
    BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT
    K Number
    K954065
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biochem Immunosystems (U.S.), Inc.
    Date Received
    August 30, 1995
    Decision Date
    July 10, 1996
    Product Code
    JHI
    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
    JHI Visual, Pregnancy Hcg, Prescription Use

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    Other Clearances by Biochem Immunosystems (U.S.), Inc.

    K Number Device Name
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    K960072 SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX
    K955102 BIODATA TESTOSTERONE MAIA KIT