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510(k) Data Aggregation

    K Number
    K982801

    Validate with FDA (Live)

    Device Name
    AUTO-LYTE PCP EIA, MODEL #1254U
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Date Cleared
    1998-11-04

    (86 days)

    Product Code
    LCM
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Toxicology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The STC AUTO-LYTE® PCP EIA is intended for use in the qualitative determination of phencyclidine in urine. This test is intended for in vitro diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry. This document does not contain the information you are looking for. This document is a letter from the FDA to STC Technologies, Inc. regarding the 510(k) premarket notification for their AUTO-LYTE® PCP EIA (Urine) device. It confirms the device's substantial equivalence to legally marketed predicate devices and outlines the regulatory requirements. It does not provide details on acceptance criteria, study designs, sample sizes, or expert qualifications related to the device's performance.

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