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

    CREATINE KINASE (CK)

    K Number: K972155 · Decision Jul 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    122
    Applicant Total
    47
    Review Days
    42

    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
    CREATINE KINASE (CK)
    K Number
    K972155
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stanbio Laboratory
    Date Received
    June 5, 1997
    Decision Date
    July 17, 1997
    Product Code
    CGS
    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
    CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

    Similar 510(k) Clearances

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

    Pointe Scientific Creatinine Kinase (CK) Reagent Set

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SEKURE Creatine Kinase Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CPK REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE

    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
    K050266 DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR
    K050283 CREATININE 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 →