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

    TARGET(TM) CK-MB

    K Number: K890295 · Decision Aug 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    39
    Applicant Total
    22
    Review Days
    208

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    Basic Information

    Device Name
    TARGET(TM) CK-MB
    K Number
    K890295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    V-Tech, Inc.
    Date Received
    January 19, 1989
    Decision Date
    August 15, 1989
    Product Code
    JHY
    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
    JHY Colorimetric Method, Cpk Or Isoenzymes

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    Other Clearances by V-Tech, Inc.

    K Number Device Name
    K914303 TARGET(TM)-HOG
    K910893 TARGET(TM) CANNABINOIDS-R TEST
    K910892 TARGET(TM) CANNABINOIDS-V TEST
    K910739 TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH)
    K910738 TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH)
    K910122 TARGET COCAINE METABOLITE-R
    K910123 TARGET COCAINE METABOLITE-V
    K903937 TARGET(TM) HOG ONE STEP
    K890978 TARGET OPIATES-R
    K890979 TARGET OPIATES-V
    Search all 22 clearances from V-Tech, Inc. →