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

    OLYMPUS CREATINE KINASE REAGENT

    K Number: K922459 · Decision Jul 13, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    122
    Applicant Total
    142
    Review Days
    48

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    Basic Information

    Device Name
    OLYMPUS CREATINE KINASE REAGENT
    K Number
    K922459
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Olympus Corp.
    Date Received
    May 26, 1992
    Decision Date
    July 13, 1992
    Product Code
    CGS
    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
    CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

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    Other Clearances by Olympus Corp.

    K Number Device Name
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    K931763 HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS
    K934835 FLOVAL
    K931764 HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES
    K915857 FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE
    K931994 RESECTOSCOPE SHEATH
    K933992 OLYMPUS SCLEROTHERAPY BALLOON
    K934361 OLYMPUS CREATININE REAGENT
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