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

    BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL

    K Number: K920525 · Decision Aug 5, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    99
    Applicant Total
    16
    Review Days
    183

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    Basic Information

    Device Name
    BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL
    K Number
    K920525
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biotrack, Inc.
    Date Received
    February 4, 1992
    Decision Date
    August 5, 1992
    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 Biotrack, Inc.

    K Number Device Name
    K934061 BIOTRACK VALPROIC ACID TEST CARTRIDGE
    K934062 BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS
    K915755 BIOTRACK PHENYTOIN TEST CARTRIDGE
    K915756 BIOTRACK CARBAMAZEPINE TEST CARTRIDGE
    K903924 BIOTRACK THEOPHYLLINE QUALITY CONTROLS
    K900373 BIOTRACK THEOPHYLLINE TEST CARTRIDGE
    K900372 BIOTRACK IMMUNOCHEMISTRY MONITOR
    K895101 BIOTRACK HEMOGLOBIN TEST CARTRIDGE
    K895102 BIOTRACK PDS MONITOR
    K895128 BIOTRACK ALT TEST CARTRIDGE
    Search all 16 clearances from Biotrack, Inc. →