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

    PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT

    K Number: K884193 · Decision Nov 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    10
    Applicant Total
    72
    Review Days
    47

    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
    PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT
    K Number
    K884193
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3400
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Baxter Diagnostics, Inc.
    Date Received
    October 6, 1988
    Decision Date
    November 22, 1988
    Product Code
    GQS
    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
    GQS Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4

    Similar 510(k) Clearances

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

    D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    IMAGEN

    FDA 510(k)
    FDA Class 1 ·Microbiology

    P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2

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

    Other Clearances by Baxter Diagnostics, Inc.

    K Number Device Name
    K934458 DRIED GRAM-POSITIVE MIC/COMBO PANELS
    K950817 DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI
    K935704 DRIED GRAM-NEGATIVE MIC//COMBO PANELS
    K950570 STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY
    K945235 DRIED GRAM-POSITIVE MIC/COMBO PANELS
    K941030 DRIED GRAM-NEGATIVE CEFPODOXIME
    K940917 LORACARBEF GRAM-NAGATIVE PANELS
    K941459 GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX
    K941317 DRIED GRAM NEGATIVE/CEFMETAZOLE
    K942089 MICRODILUTION/LORACARBEF PANELS
    Search all 72 clearances from Baxter Diagnostics, Inc. →