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510(k) Data Aggregation

    K Number
    K953672
    Device Name
    FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS
    Manufacturer
    POLYMER TECHNOLOGY INTL.
    Date Cleared
    1996-07-01

    (329 days)

    Product Code
    JMT
    Regulation Number
    862.1510
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMER TECHNOLOGY INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K953661
    Device Name
    FIRST CHOICE GLUCOSE URINE TEST STRIPS
    Manufacturer
    POLYMER TECHNOLOGY INTL.
    Date Cleared
    1996-06-14

    (312 days)

    Product Code
    JIL
    Regulation Number
    862.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMER TECHNOLOGY INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K953662
    Device Name
    FIRST CHOICE KETONES URINE TEST STRIPS
    Manufacturer
    POLYMER TECHNOLOGY INTL.
    Date Cleared
    1996-06-14

    (312 days)

    Product Code
    JIN
    Regulation Number
    862.1435
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMER TECHNOLOGY INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K953680
    Device Name
    FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS
    Manufacturer
    POLYMER TECHNOLOGY INTL.
    Date Cleared
    1996-06-12

    (310 days)

    Product Code
    JIN
    Regulation Number
    862.1435
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMER TECHNOLOGY INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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