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

    FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY

    K Number: K884047 · Decision Mar 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    6
    Applicant Total
    20
    Review Days
    169

    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
    FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY
    K Number
    K884047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Disease Detection International, Inc.
    Date Received
    September 26, 1988
    Decision Date
    March 14, 1989
    Product Code
    LYF
    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
    LYF Pneumocystis Carinii

    Similar 510(k) Clearances

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

    LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FUNGI FLUOR KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    STAINING SYSTEM FOR PNEUMOCYSTIS CARINII

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MERIFLUOR TM PNEUMOCYSTIS MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MERIFLUOR(TM) PNEUMOCYSTIS

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

    Other Clearances by Disease Detection International, Inc.

    K Number Device Name
    K943252 PRO-STEP LH OVULATION PREDICTION TEST
    K925303 PRO-STEP PT HCG
    K925125 PRO-STEP HCG
    K911826 IMMUNOCARD HCG ONE STEP (I-S) TEST KIT
    K902571 MODIFICATION OF SEROCARD RUBELLA IGG TEST
    K903070 SEROCARD HSV IGG ANTIBODY TEST KIT
    K895912 IMMUNOCARD HCG II-S TEST KIT
    K896109 IMMUNOCARD STREP A TEST
    K884247 MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT
    K884248 MODIFIED DDI SEROCARD CMV IGG TEST KIT
    Search all 20 clearances from Disease Detection International, Inc. →