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

    GLUCOSE REAGENT SET

    K Number: K855185 · Decision Jan 22, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    11
    Applicant Total
    21
    Review Days
    27

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    Basic Information

    Device Name
    GLUCOSE REAGENT SET
    K Number
    K855185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Technostics Intl.
    Date Received
    December 26, 1985
    Decision Date
    January 22, 1986
    Product Code
    CGE
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CGE Orthotoluidine, Glucose

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    Other Clearances by Technostics Intl.

    K Number Device Name
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    K860110 GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET
    K860109 ENZYMATIC UREA NITROGEN REAGENT SET
    K860112 TOTAL LIPIDS REAGENT SET
    K855157 LACTIC DEHYDROGENASE (VV) REAGENT SET
    K855194 GLUCOSE OXIDASE REAGENT SET
    K855153 GLUCOSE (UV HEXOKIASE) REAGENT SET
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    Search all 21 clearances from Technostics Intl. →