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

    ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST

    K Number: K881500 · Decision Apr 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    34
    Applicant Total
    126
    Review Days
    16

    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
    ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST
    K Number
    K881500
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Diagnostic Systems, Inc.
    Date Received
    April 11, 1988
    Decision Date
    April 27, 1988
    Product Code
    LJP
    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
    LJP Antiserum, Fluorescent, Chlamydia Trachomatis

    Similar 510(k) Clearances

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

    DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CHLAMYDIA TRACHOMATIS ANTIGEN TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1

    FDA 510(k)
    FDA Class 1 ·Microbiology

    FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI

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

    Other Clearances by Ortho Diagnostic Systems, Inc.

    K Number Device Name
    K951459 ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
    K951632 ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)
    K964754 ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
    K963902 QUANTITATIVE FIBRINOGEN ASSAY
    K950625 ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)
    K951100 ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)
    K950568 ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)
    K950482 ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)
    K935720 ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM
    K954570 ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM
    Search all 126 clearances from Ortho Diagnostic Systems, Inc. →