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

    RAPID YEAST PLUS SYSTEM

    K Number: K943621 · Decision Jan 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    15
    Applicant Total
    11
    Review Days
    184

    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
    RAPID YEAST PLUS SYSTEM
    K Number
    K943621
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Innovative Diagnostic Systems, Inc.
    Date Received
    July 27, 1994
    Decision Date
    January 27, 1995
    Product Code
    JXB
    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
    JXB Kit, Identification, Yeast

    Similar 510(k) Clearances

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

    YEAST TRAFFIC LIGHT PNA FISH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    C. ALBICANS PNA FISH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    YEASTEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BACTICARD CANDIDA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MICRORING YT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    VITEK YEAST BIOCHEMICAL CARD

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

    Other Clearances by Innovative Diagnostic Systems, Inc.

    K Number Device Name
    K962966 IDS RAPID CB PLUS SYSTEM
    K900517 RAPID NF SYSTEM
    K882960 IDS RAPID ANA SYSTEM
    K881501 MODIFIED IDS RAPID NH SYSTEM
    K852871 IDS RAPID SS/U SYSTEM
    K852110 IDS RAPID E PLUS SYSTEM
    K833654 IDS RAPID STR SYSTEM
    K822144 IDS STAPHYLOCHROME TEST
    K820483 IDA RAPID O2A SYSTEM
    K812859 IDS PORPHYRIN REAGENT
    Search all 11 clearances from Innovative Diagnostic Systems, Inc. →