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

    ACS:CENTAUR AFP

    K Number: K981592 · Decision Jul 7, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    20
    Review Days
    64

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    Basic Information

    Device Name
    ACS:CENTAUR AFP
    K Number
    K981592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chiron Diagnostics Corp.
    Date Received
    May 4, 1998
    Decision Date
    July 7, 1998
    Product Code
    LOQ
    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
    LOQ Device, General Purpose, Hematology

    Other Clearances by Chiron Diagnostics Corp.

    K Number Device Name
    K992157 CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY
    K991582 CHIRON DIAGNOSTICS ACS: 180 FOLATE
    K991692 CHIRON DIAGNOSTICS ACS: 180 FT3
    K982680 CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
    K981478 ACS:CENTAUR CEA
    K981839 ACS:CENTAUR PSA2 IMMUNOASSAY
    K980528 CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)
    K974029 ACS TOBRAMYCIN
    K974325 CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN
    K970695 ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
    Search all 20 clearances from Chiron Diagnostics Corp. →