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

    PARA-PAK

    K Number: K811377 · Decision Jun 16, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    327
    Applicant Total
    92
    Review Days
    32

    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
    PARA-PAK
    K Number
    K811377
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1620
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Meridian Diagnostics, Inc.
    Date Received
    May 15, 1981
    Decision Date
    June 16, 1981
    Product Code
    JTN
    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
    JTN Susceptibility Test Discs, Antimicrobial

    Similar 510(k) Clearances

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

    HardyDisk AST Gepotidacin 10µg (GEP10)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HardyDisk AST Cefiderocol 30µg (FDC30)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Sulopenem SPM 2 µg

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HardyDisk AST Gepotidacin 10µg (GEP10)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Ceftobiprole BPR 5 µg Disc

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

    Other Clearances by Meridian Diagnostics, Inc.

    K Number Device Name
    K993914 PREMIER TOXINS A&B, MODEL 616096
    K990263 IMMUNOCARD STAT! E. COLI O157:H7
    K984346 PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST
    K984343 PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST
    K983255 MODIFICATION TO: PREMIER PLATINUM HPSA
    K982764 PREMIER CRYPTOSPORIDIUM
    K982711 PREMIER GIARDIA
    K980076 PREMIER PLATINUM HPSA
    K980077 PARA-PAK SPINCON
    K971585 IMMUNOCARD STAT! ROTAVIRUS
    Search all 92 clearances from Meridian Diagnostics, Inc. →