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

    MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR

    K Number: K900708 · Decision Apr 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    30
    Applicant Total
    28
    Review Days
    66

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    Basic Information

    Device Name
    MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR
    K Number
    K900708
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3950
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Innotron of Oregon, Inc.
    Date Received
    February 12, 1990
    Decision Date
    April 19, 1990
    Product Code
    LEH
    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
    LEH Radioimmunoassay, Vancomycin

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    K900704 MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA
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    K900702 MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA
    K895827 INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET
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