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

    LEECO P.A.P. - QUANT DIAGNOSTIC KIT

    K Number: K810232 · Decision Feb 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    44
    Applicant Total
    49
    Review Days
    14

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    Basic Information

    Device Name
    LEECO P.A.P. - QUANT DIAGNOSTIC KIT
    K Number
    K810232
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Leeco Diagnostics, Inc.
    Date Received
    January 27, 1981
    Decision Date
    February 10, 1981
    Product Code
    JFH
    Advisory Committee
    Clinical Chemistry
    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
    JFH Acid Phosphatase (Prostatic), Tartrate Inhibited

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    K891096 VIS-DISK HCG (EIA) JPL-041M
    K883269 PRL-QUANT
    K880577 CONCEP-7-BHCG
    K880069 LEECO PREGNASTICK (EIA) CATALOG #003
    K870259 VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044
    K864170 LEECO VIS-CUBE STREP A (EIA)
    K863999 VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042
    Search all 49 clearances from Leeco Diagnostics, Inc. →