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

    BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC

    K Number: K874175 · Decision Dec 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    86
    Applicant Total
    8
    Review Days
    52

    Basic Information

    Device Name
    BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC
    K Number
    K874175
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2320
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    OTISVILLE BIOPHARM, INC.
    Date Received
    October 13, 1987
    Decision Date
    December 4, 1987
    Product Code
    JSF
    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
    JSF Culture Media, Single Biochemical Test

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JSF), ordered by most recent decision date.

    NUTRIENT GELATIN - PRODUCT NUMBER T2860

    FDA 510(k)
    FDA Class 1 ·Microbiology

    LAURYL TRYPTOSE BROTH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MOELLERS DECARBOXYLASE, LYSINE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MOELLERS DECARBOXYLASE, ONITHINE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ACETAMIDE AGAR SLANT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NITRATE BROTH

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by OTISVILLE BIOPHARM, INC.

    K Number Device Name
    K874176 BIOTIS (TM) HAEMOPHILUS DUCREYI
    K874179 BIOTIS (TM) SABHI (DOUBLE POUR)
    K874177 BIOTIS (TM) BCYE
    K874178 BIOTIS (TM) BCYE SELECTIVE
    K874174 BIOTIS (TM) STARCH HYDROLYSIS WITH BCP
    K874172 BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR)
    K874173 BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI