BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    UROTEST GPH

    K Number: K912244 · Decision Nov 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    185

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    UROTEST GPH
    K Number
    K912244
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3560
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    In Wha Pharmaceutical Co., Ltd.
    Date Received
    May 21, 1991
    Decision Date
    November 22, 1991
    Product Code
    JII
    Advisory Committee
    Clinical Toxicology
    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
    JII Atomic Absorption, Lithium

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JII), ordered by most recent decision date.

    DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DIAZYME LITHIUM ENZYMATIC ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
    View all