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

    INNOFLUOR VANCOMYCIN CALIBRATOR SET

    K Number: K872644 · Decision Jul 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    122
    Applicant Total
    28
    Review Days
    15

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    Basic Information

    Device Name
    INNOFLUOR VANCOMYCIN CALIBRATOR SET
    K Number
    K872644
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Innotron of Oregon, Inc.
    Date Received
    July 6, 1987
    Decision Date
    July 21, 1987
    Product Code
    DLJ
    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
    DLJ Calibrators, Drug Specific

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    Other Clearances by Innotron of Oregon, Inc.

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    K900707 MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR
    K900708 MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR
    K900704 MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA
    K900703 MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR
    K900705 MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR
    K900706 MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA
    K900702 MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA
    K895827 INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET
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