BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    DAPTOMYCIN

    K Number: K042392 · Decision Dec 13, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    433
    Applicant Total
    64
    Review Days
    102

    Basic Information

    Device Name
    DAPTOMYCIN
    K Number
    K042392
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    AB BIODISK
    Date Received
    September 2, 2004
    Decision Date
    December 13, 2004
    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

    Similar 510(k) Clearances

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

    The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by AB BIODISK

    K Number Device Name
    K081325 ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML
    K052366 ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA
    K042390 ETEST FOR GEMIFLOXACIN
    K040560 ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
    K021445 ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE
    K020748 ETEST ERTAPENEM
    K010363 ETEST MEROPENEM
    K002139 ETEST LINEZOLID
    K001547 ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP
    K000596 ETEST GATIFLOXACIN
    Search all 64 clearances from AB BIODISK →