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

    AVOCET PT

    K Number: K980839 · Decision Sep 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    180
    Applicant Total
    4
    Review Days
    210

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    Basic Information

    Device Name
    AVOCET PT
    K Number
    K980839
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avocet Medical, Inc.
    Date Received
    March 4, 1998
    Decision Date
    September 30, 1998
    Product Code
    JPA
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JPA System, Multipurpose For In Vitro Coagulation Studies

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    Other Clearances by Avocet Medical, Inc.

    K Number Device Name
    K994006 AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)
    K991286 AVOCET ACUSURE SYSTEM
    K980982 AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2