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

    PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)

    K Number: K943317 · Decision Dec 19, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    22
    Applicant Total
    321
    Review Days
    161

    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
    PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)
    K Number
    K943317
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3480
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Products Corp.
    Date Received
    July 11, 1994
    Decision Date
    December 19, 1994
    Product Code
    LKT
    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
    LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa

    Similar 510(k) Clearances

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

    D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1

    FDA 510(k)
    FDA Class 1 ·Microbiology

    RSV ANTIGEN TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    RSV-MAB TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BIOMERIEUX RSV DIRECT IF KIT

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

    Other Clearances by Diagnostic Products Corp.

    K Number Device Name
    K063045 IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
    K034055 IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
    K033234 IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
    K032881 IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
    K023152 IMMULITE 2000 ALLERGEN-SPECIFIC IGE
    K023304 IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
    K022603 IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
    K022118 IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
    K021257 ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
    K021208 IMMULITE 2000 MIXED ALLERGEN PANELS
    Search all 321 clearances from Diagnostic Products Corp. →