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

    ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)

    K Number: K935055 · Decision Aug 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    11
    Applicant Total
    296
    Review Days
    293

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    Basic Information

    Device Name
    ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)
    K Number
    K935055
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3640
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Roche Diagnostic Systems, Inc.
    Date Received
    October 20, 1993
    Decision Date
    August 9, 1994
    Product Code
    DOE
    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
    DOE Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.

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    Other Clearances by Roche Diagnostic Systems, Inc.

    K Number Device Name
    K983698 MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
    K983702 MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES
    K983704 MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
    K983556 ABUSCREEN ONLINE BENZ 300 CALIBRATORS
    K983555 ABUSCREEN ONLINE BENZ 200 CALIBRATORS
    K983697 MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
    K983700 MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE
    K983701 MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
    K983699 MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES
    K983703 MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE
    Search all 296 clearances from Roche Diagnostic Systems, Inc. →