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

    AUTO-LYTE BARBITURATES EIA

    K Number: K982745 · Decision Nov 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    99
    Applicant Total
    30
    Review Days
    104

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    Basic Information

    Device Name
    AUTO-LYTE BARBITURATES EIA
    K Number
    K982745
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    OraSure Technologies, Inc.
    Date Received
    August 6, 1998
    Decision Date
    November 18, 1998
    Product Code
    DIS
    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
    DIS Enzyme Immunoassay, Barbiturate

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    Other Clearances by OraSure Technologies, Inc.

    K Number Device Name
    DEN190025 OraQuick Ebola Rapid Antigen Test
    K060859 COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
    K023487 HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
    K013882 OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
    K020371 UPLINK TEST SYSTEM
    K011057 INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
    K002375 STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
    K001976 STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
    K002010 STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
    K000399 STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
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