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510(k) Data Aggregation

    K Number
    K131479
    Device Name
    V8 SP NORMAL CONTROL, ABNORMAL CONTROL
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    2013-10-07

    (138 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    V8 SP NORMAL CONTROL, ABNORMAL CONTROL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    V8 SP Normal Control is to be used as a qualitative control for serum protein by Helena V8 Capillary Electrophoresis (CE) System.

    V8 SP Abnormal Control is to be used as a qualitative control for serum protein by Helena V8 Capillary Electrophoresis (CE) System.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but this document contains no information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification letter from the FDA to Helena Laboratories for a device called "V8 SP Normal Control and V8 SP Abnormal Control". It primarily discusses the regulatory classification of the device and general compliance requirements, but does not include any performance data or study details.

    Therefore, I cannot provide the requested information based on the provided text.

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