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

    BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117

    K Number: K022660 · Decision Dec 19, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    23
    Applicant Total
    14
    Review Days
    132

    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
    BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117
    K Number
    K022660
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2050
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biocheck, Inc.
    Date Received
    August 9, 2002
    Decision Date
    December 19, 2002
    Product Code
    DRR
    Advisory Committee
    Cardiovascular
    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
    DRR Amplifier And Signal Conditioner, Biopotential

    Similar 510(k) Clearances

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

    EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EP AMP, MODEL #901

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HORIZON 9000/HIS OPTION AMPLIFIER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIOLAB AMPLIFIER MODULE (CAM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASC-952 PHYSIOLOGICAL AMPLIFIER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Biocheck, Inc.

    K Number Device Name
    K041619 BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
    K040030 BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114
    K013062 BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
    K003851 BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119
    K002294 BIOCHECK TESTOSTERONE EIA, MODEL BC-1115
    K001022 BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061
    K992517 BIOCHECK FERRITIN ELISA MODEL BC-1025
    K992528 BIOCHECK IGE ELISA, MODEL BC-1035
    K991741 BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
    K991146 TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001
    Search all 14 clearances from Biocheck, Inc. →