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

    CARESIDE CK

    K Number: K990439 · Decision Apr 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    22
    Review Days
    67

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    Basic Information

    Device Name
    CARESIDE CK
    K Number
    K990439
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Careside, Inc.
    Date Received
    February 11, 1999
    Decision Date
    April 19, 1999
    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 Careside, Inc.

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    K002792 CARESIDE CHOLINESTERASE
    K001462 CARESIDE HEMOGLOBIN
    K993771 CARESIDE DIRECT BILIRUBIN
    K993634 CARESIDE ANALYZER
    K992475 CARESIDE CO2, TOTAL
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