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

    BETA-HCG RIA

    K Number: K772039 · Decision Nov 23, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    6
    Review Days
    26

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    Basic Information

    Device Name
    BETA-HCG RIA
    K Number
    K772039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Monitor Science Corp.
    Date Received
    October 28, 1977
    Decision Date
    November 23, 1977
    Product Code
    JHI
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    IM
    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 Monitor Science Corp.

    K Number Device Name
    K790580 RIA KIT, PROSTATIC ACID
    K780949 BIO-MONITOR AMIKACIN
    K780950 BIO-MONITOR TOBRAMYCIN
    K780951 BIO-MONITOR GENTAMICIN
    K772038 KANAMYCIN RIA