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

    SPQ TEST SYSTEM FOR HAPTOGLOBIN

    K Number: K850584 · Decision Mar 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    17
    Applicant Total
    10
    Review Days
    20

    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
    SPQ TEST SYSTEM FOR HAPTOGLOBIN
    K Number
    K850584
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5460
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Applications Lab
    Date Received
    February 13, 1985
    Decision Date
    March 5, 1985
    Product Code
    DAD
    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
    DAD Haptoglobin, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    K-ASSAY HAPTOGLOBIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    TINA-QUANT HAPTOGLOBIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    N-ASSAY TIA MULTI V-NL

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT

    FDA 510(k)
    FDA Class 2 ·Immunology

    N/T PROTEIN CONTROL SY/L, M AND H

    FDA 510(k)
    FDA Class 2 ·Immunology

    IL TEST(TM) HAPTOGLOBIN (HPT)

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

    Other Clearances by Applications Lab

    K Number Device Name
    K850587 SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN
    K850586 SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M
    K850588 SPQ TEST SYSTEM FOR COMPLEMENT C3
    K850589 SPQ TEST SYSTEM FOR TRANSFERRIN
    K850603 SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN
    K850590 SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN
    K850583 SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G
    K850582 SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A
    K850585 SPQ TEST SYSTEM FOR COMPLEMENT C4