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

    FOX FASTIDIOUS TEST PANEL

    K Number: K854525 · Decision Apr 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    281
    Review Days
    149

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    FOX FASTIDIOUS TEST PANEL
    K Number
    K854525
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Beckman Instruments, Inc.
    Date Received
    November 13, 1985
    Decision Date
    April 11, 1986
    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.

    ETEST Gepotidacin (GEP) (0.016-256 µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MTS Gepotidacin 0.016-256 µg/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MTS Aztreonam-Avibactam 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 Colistin in the dilution range of 0.12-16 ug/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL

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

    Other Clearances by Beckman Instruments, Inc.

    K Number Device Name
    K973448 ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469
    K982250 ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
    K981403 IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
    K981354 ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
    K980173 ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
    K974816 ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
    K974564 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
    K974110 IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
    K974452 VIGIL LIPID CONTROL
    K973932 BECKMAN CALIBRATOR 2 (CAL2)
    Search all 281 clearances from Beckman Instruments, Inc. →