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

    CPK (UV) REAGENT KIT

    K Number: K855188 · Decision Mar 5, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    21
    Review Days
    69

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    Basic Information

    Device Name
    CPK (UV) REAGENT KIT
    K Number
    K855188
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Technostics Intl.
    Date Received
    December 26, 1985
    Decision Date
    March 5, 1986
    Product Code
    JHS
    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
    JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes

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    Other Clearances by Technostics Intl.

    K Number Device Name
    K860111 URIC ACID REAGENT SET
    K855190 MAGNESIUM REAGENT SET
    K860110 GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET
    K860109 ENZYMATIC UREA NITROGEN REAGENT SET
    K860112 TOTAL LIPIDS REAGENT SET
    K855185 GLUCOSE REAGENT SET
    K855157 LACTIC DEHYDROGENASE (VV) REAGENT SET
    K855194 GLUCOSE OXIDASE REAGENT SET
    K855153 GLUCOSE (UV HEXOKIASE) REAGENT SET
    K855193 CREATININE REAGENT SET
    Search all 21 clearances from Technostics Intl. →