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

    PRECEPT(TM) CIPROFLOXACIN

    K Number: K874727 · Decision Feb 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    45
    Review Days
    92

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    Basic Information

    Device Name
    PRECEPT(TM) CIPROFLOXACIN
    K Number
    K874727
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Austin Biological Laboratories
    Date Received
    November 18, 1987
    Decision Date
    February 18, 1988
    Product Code
    JWY
    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
    JWY Manual Antimicrobial Susceptibility Test Systems

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    Other Clearances by Austin Biological Laboratories

    K Number Device Name
    K880511 XACT NEISSERIA
    K870769 AUSTIN NONFERMENTER KIT
    K864069 PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID
    K862560 PRECEPT CEFTIZOXIME
    K862446 PRECEPT CEFTAZIDIME
    K860195 PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE
    K860194 AUSTIN ENTERIC SYSTEM
    K854577 PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN)
    K853772 PRECEPT METHICILLIN
    K853596 PRECEPT CEFOPERAZONE
    Search all 45 clearances from Austin Biological Laboratories →