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

    SERA-TEK THYROGLOBULIN ANTIBODY TEST

    K Number: K865020 · Decision Feb 2, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    158
    Review Days
    41

    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
    SERA-TEK THYROGLOBULIN ANTIBODY TEST
    K Number
    K865020
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Miles Laboratories, Inc.
    Date Received
    December 23, 1986
    Decision Date
    February 2, 1987
    Product Code
    DDC
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DDC Thyroglobulin, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    SERAQUEST ANTI-THYROGLOBULIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895

    FDA 510(k)
    FDA Class 2 ·Immunology

    MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.

    FDA 510(k)
    FDA Class 2 ·Immunology

    ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA

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

    Other Clearances by Miles Laboratories, Inc.

    K Number Device Name
    K880605 LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
    K874909 MICRO-BUMINTEST REAGENT TABLETS
    K875079 MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE
    K871835 GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
    K872120 SERALYZER III BLOOD CHEMISTRY ANALYZER
    K873304 CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)
    K872634 CUTTER PUREFLO PLUS IV FILTER
    K870214 MODIFIED SALTEX REAGENT STRIPS
    K870752 SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS
    K865053 SERA-TEK MICROSOMAL ANTIBODY TEST
    Search all 158 clearances from Miles Laboratories, Inc. →