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

    MARTIN LEWIS AGAR CSI 3169

    K Number: K791447 · Decision Sep 17, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    82
    Applicant Total
    30
    Review Days
    48

    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
    MARTIN LEWIS AGAR CSI 3169
    K Number
    K791447
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.2410
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Clinical Sciences, Inc.
    Date Received
    July 31, 1979
    Decision Date
    September 17, 1979
    Product Code
    JTY
    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
    JTY Culture Media, For Isolation Of Pathogenic Neisseria

    Similar 510(k) Clearances

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

    InTray GC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INTRAY GC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GC BASE W/ 1% GCHI

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR

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

    Other Clearances by Clinical Sciences, Inc.

    K Number Device Name
    K900688 VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT
    K883870 EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590
    K883871 EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590
    K891990 RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600
    K883600 EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550
    K883601 EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550
    K874594 TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560
    K872942 IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530
    K860145 RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540
    K860773 TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560
    Search all 30 clearances from Clinical Sciences, Inc. →