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

    LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL

    K Number: K133960 · Decision Jan 22, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    672
    Applicant Total
    44
    Review Days
    29

    Basic Information

    Device Name
    LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL
    K Number
    K133960
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Rad Laboratories
    Date Received
    December 24, 2013
    Decision Date
    January 22, 2014
    Product Code
    JJY
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JJY Multi-Analyte Controls, All Kinds (Assayed)

    Similar 510(k) Clearances

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

    Multichem IA Plus

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Audit MicroControls Linearity FD Tumor Markers II

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Liquichek Cardiac Markers Plus Control LT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VALIDATE Anemia Calibration Verification/ Linearity Test Kit

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Bio-Rad Laboratories

    K Number Device Name
    K183446 BioPlex 2200 Lyme Total
    K180577 BioPlex 2200 25-OH Vitamin D Kit
    K170509 BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
    K170413 BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
    DEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak
    K150300 Liquichek Cardiac Markers Plus Control LT
    K143379 Liquichek Maternal Serum II Control
    K141114 BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D
    K141073 LIQUICHEK TUMOR MARKER CONTROL
    K140916 LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK
    Search all 44 clearances from Bio-Rad Laboratories →