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

    CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS

    K Number: K944604 · Decision Dec 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    11
    Review Days
    79

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    Basic Information

    Device Name
    CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS
    K Number
    K944604
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman-Diagnostic Systems Group
    Date Received
    September 19, 1994
    Decision Date
    December 7, 1994
    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 Beckman-Diagnostic Systems Group

    K Number Device Name
    K945522 I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS
    K944605 CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM
    K944606 CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS
    K942676 SYNCHRON CX3 DELTA
    K934293 BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT
    K934068 BECKMAN DIRECT BILIRUBIN REAGENT
    K936184 VIGIL PRX CHEMISTRY CONTROL
    K934271 BECKMAN SYNCHRON LACTATE REAGENT
    K934046 BECKMAN CHOLESTEROL REAGENT
    K934467 BECKMAN CX AMMONIA/ALCOHOL CONTROL
    Search all 11 clearances from Beckman-Diagnostic Systems Group →