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

    ANTIASTHMATIC CALIBRATORS

    K Number: K862964 · Decision Aug 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    122
    Applicant Total
    73
    Review Days
    13

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    Basic Information

    Device Name
    ANTIASTHMATIC CALIBRATORS
    K Number
    K862964
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    American Monitor Corp.
    Date Received
    August 6, 1986
    Decision Date
    August 19, 1986
    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 American Monitor Corp.

    K Number Device Name
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    K895423 ACCESS CHEMISTRY ANALYZER
    K893137 EXCEL (TM) CHEMISTRY ANALYZER
    K892331 ENZYMATIC UREA NITROGEN REAGENT SET
    K893479 CHOLESTEROL REAGENT SET
    K892002 NEOCHROME(R) III GLUCOSE
    K890312 GAMMA-GLUTAMYLTRANSFERASE
    K890034 PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY)
    Search all 73 clearances from American Monitor Corp. →