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

    STC DIAGNOSTICS AUTO-LYTE AMPHETAMINES EIA

    K Number: K930690 · Decision Apr 16, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    28
    Review Days
    65

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    Basic Information

    Device Name
    STC DIAGNOSTICS AUTO-LYTE AMPHETAMINES EIA
    K Number
    K930690
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Solarcare Technologies Corp,Inc.
    Date Received
    February 10, 1993
    Decision Date
    April 16, 1993
    Product Code
    DKZ
    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
    DKZ Enzyme Immunoassay, Amphetamine

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    Other Clearances by Solarcare Technologies Corp,Inc.

    K Number Device Name
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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
    K935565 OPIATES MICRO-PLATE ASSAY
    K950308 STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA
    Search all 28 clearances from Solarcare Technologies Corp,Inc. →