BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TARGET STREP A

    K Number: K880460 · Decision Mar 3, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    104
    Applicant Total
    22
    Review Days
    29

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    Basic Information

    Device Name
    TARGET STREP A
    K Number
    K880460
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    V-Tech, Inc.
    Date Received
    February 3, 1988
    Decision Date
    March 3, 1988
    Product Code
    GTZ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GTZ Antisera, All Groups, Streptococcus Spp.

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    Other Clearances by V-Tech, Inc.

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    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. →