LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K973154
    Device Name
    UBI MAGIWEL MARIJUANA METABOLITES
    Manufacturer
    UNITED BIOTECH, INC.
    Date Cleared
    1998-07-22

    (334 days)

    Product Code
    LDJ
    Regulation Number
    862.3870
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The UBI MAGIWEL™ Marijuana metabolites is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides qualitative measurement of Marijuana metabolites in human urine. (for Professional use only)

    Device Description

    solid phase enzyme-linked immunosorbent assay(ELISA)

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment.

    Instead, the letter primarily focuses on the FDA's determination of substantial equivalence for the "UBI MAGIWEL Marijuana Metabolites" device, its regulatory class, and the general controls and regulations it is subject to. It also outlines responsibilities of the manufacturer regarding CLIA categorization, labeling, promotion, and advertising.

    Therefore, I cannot extract the requested information from the provided input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1