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

    DOA - IMMUNOASSAY CUT-OFF CALIBRATOR

    K Number: K945289 · Decision Dec 13, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    93
    Applicant Total
    36
    Review Days
    43

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    Basic Information

    Device Name
    DOA - IMMUNOASSAY CUT-OFF CALIBRATOR
    K Number
    K945289
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medi-Tech, Inc.
    Date Received
    October 31, 1994
    Decision Date
    December 13, 1994
    Product Code
    DKB
    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
    DKB Calibrators, Drug Mixture

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    Other Clearances by Medi-Tech, Inc.

    K Number Device Name
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    K942551 THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED
    K943290 BILIRUBIN PLUS/PEDIATRIC CONTROLS
    K922990 HEMODIALYSIS BATH
    K942552 THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED
    K904073 COAGULATION REFERENCE PLASMA, ABNORMAL
    K895819 MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL
    K873295 PROSTATIC URETHRO. BALLOON DILATATION CATHETER
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