BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CSF TOTAL PROTEIN TEST SET #0340

    K Number: K780110 · Decision Mar 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    12
    Applicant Total
    47
    Review Days
    43

    Basic Information

    Device Name
    CSF TOTAL PROTEIN TEST SET #0340
    K Number
    K780110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1635
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    STANBIO LABORATORY
    Date Received
    January 19, 1978
    Decision Date
    March 3, 1978
    Product Code
    JGQ
    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
    JGQ Turbidimetric, Total Protein

    Similar 510(k) Clearances

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

    HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TOTAL PROTEIN URINE/CSF GEN.3

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UPRO

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UPRO

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TRACE MICROPROTEIN REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by STANBIO LABORATORY

    K Number Device Name
    K090093 STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM
    K081719 STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
    K050283 CREATININE LIQUICOLOR
    K050266 DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR
    K042169 STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER
    K041155 WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
    K032936 DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR
    K032932 DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR
    K032482 STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
    K020378 QUPID PLUS E.R.
    Search all 47 clearances from STANBIO LABORATORY →