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

    STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA

    K Number: K944372 · Decision Feb 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    21
    Applicant Total
    6
    Review Days
    154

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    Basic Information

    Device Name
    STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA
    K Number
    K944372
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3700
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Solarcare, Inc.
    Date Received
    September 7, 1994
    Decision Date
    February 8, 1995
    Product Code
    JXN
    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
    JXN Enzyme Immunoassay, Propoxyphene

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    Other Clearances by Solarcare, Inc.

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    K941497 SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY
    K934376 STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA
    K933327 HISTOFREEZER