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

    ACCESS CHLAMYDIA ASSAY

    K Number: K960850 · Decision Feb 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    66
    Applicant Total
    82
    Review Days
    340

    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
    ACCESS CHLAMYDIA ASSAY
    K Number
    K960850
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Rad Laboratories, Inc.
    Date Received
    March 1, 1996
    Decision Date
    February 4, 1997
    Product Code
    LJC
    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
    LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)

    Similar 510(k) Clearances

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

    CT OIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    IDEIA PCE CHLAMYDIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CHLAMYDIA IGG ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CHLAMYDIA IGG ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    VIDAS CHLAMYDIA BLOCKING ASSAY

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

    Other Clearances by Bio-Rad Laboratories, Inc.

    K Number Device Name
    K181661 QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
    K171664 Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
    K161687 D-10 Hemoglobin A1c Program
    K151321 D-100 HbA1c, D-100 HbA1c Calibrator Pack
    K142448 VARIANT II TURBO HbA1c Kit - 2.0
    K140801 VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
    K130053 BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI
    K130963 LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK
    K120504 LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
    K120572 BIOPLEX 2200 TORC IGG
    Search all 82 clearances from Bio-Rad Laboratories, Inc. →