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

    PRECISE TM HCG

    K Number: K915197 · Decision Dec 17, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    10
    Review Days
    28

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    Basic Information

    Device Name
    PRECISE TM HCG
    K Number
    K915197
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Becton Dickinson Advanced Diagnostics
    Date Received
    November 19, 1991
    Decision Date
    December 17, 1991
    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 Becton Dickinson Advanced Diagnostics

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    K926356 PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG
    K925132 BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE
    K923673 PRECISE STREP A
    K923060 IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY
    K914958 RIATRAC PLUS
    K915200 PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA