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

    AUTO-LYTE METHADONE DIA

    K Number: K944056 · Decision Dec 29, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    62
    Applicant Total
    28
    Review Days
    132

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    Basic Information

    Device Name
    AUTO-LYTE METHADONE DIA
    K Number
    K944056
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3620
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Solarcare Technologies Corp,Inc.
    Date Received
    August 19, 1994
    Decision Date
    December 29, 1994
    Product Code
    DJR
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DJR Enzyme Immunoassay, Methadone

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    Other Clearances by Solarcare Technologies Corp,Inc.

    K Number Device Name
    K954326 STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY
    K954156 STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY
    K955905 STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
    K954158 STC DIAGNOSTICS AUTO-LYTE PH ASSAY
    K940048 STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION
    K954073 STC DIAGNOSTICS LSD MICRO-PLATE EIA
    K954266 STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY
    K935573 AMPHETAMINES MICRO-PLATE EIA
    K935565 OPIATES MICRO-PLATE ASSAY
    K950308 STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA
    Search all 28 clearances from Solarcare Technologies Corp,Inc. →