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

    STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION

    K Number: K940048 · Decision Mar 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    122
    Applicant Total
    28
    Review Days
    804

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    Basic Information

    Device Name
    STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION
    K Number
    K940048
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Solarcare Technologies Corp,Inc.
    Date Received
    January 5, 1994
    Decision Date
    March 19, 1996
    Product Code
    DLJ
    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
    DLJ Calibrators, Drug Specific

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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
    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
    K944056 AUTO-LYTE METHADONE DIA
    Search all 28 clearances from Solarcare Technologies Corp,Inc. →