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

    OPIATES MICRO-PLATE ASSAY

    K Number: K935565 · Decision Jul 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    28
    Review Days
    603

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    Basic Information

    Device Name
    OPIATES MICRO-PLATE ASSAY
    K Number
    K935565
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Solarcare Technologies Corp,Inc.
    Date Received
    November 18, 1993
    Decision Date
    July 14, 1995
    Product Code
    DJG
    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
    DJG Enzyme Immunoassay, Opiates

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    Other Clearances by Solarcare Technologies Corp,Inc.

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    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
    K950308 STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA
    K944056 AUTO-LYTE METHADONE DIA
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