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

    IMMULITE DIGOXIN

    K Number: K914833 · Decision Nov 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    13
    Applicant Total
    10
    Review Days
    28

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    Basic Information

    Device Name
    IMMULITE DIGOXIN
    K Number
    K914833
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cirrus Diagnostics, Inc.
    Date Received
    October 25, 1991
    Decision Date
    November 22, 1991
    Product Code
    DPO
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DPO Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.

    Similar 510(k) Clearances

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

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    COAT-A-COUNT DIGOXIN RIA

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    Other Clearances by Cirrus Diagnostics, Inc.

    K Number Device Name
    K921704 IMMULITE(R) FSH
    K920411 IMMULITE HLH
    K911796 IMMULITE(TM) HCG
    K910677 IMMULITE(TM) T-UPTAKE
    K910261 IMMULITE(TM) TOTAL T4
    K905648 CRP LIPID REAGENT TEST PACK
    K905214 IMMULITE (TM) TOTAL T3
    K905769 IMMULITE HS-TSH
    K905215 IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER