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510(k) Data Aggregation

    K Number
    K982151
    Device Name
    STERITITE PROCESS INDICATOR ACCESSORIES
    Manufacturer
    CASE MEDICAL, INC.
    Date Cleared
    1999-02-09

    (236 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Process indicators are intended for the use with individual units, to demonstrate that the unit has been exposed to a process at stated conditions and distinguish between processed and unprocessed units.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Steritite Process Indicator Accessories". It does not contain the detailed study information, acceptance criteria, or performance data typically found in a scientific paper or a more comprehensive regulatory submission. The letter confirms substantial equivalence to a predicate device and allows market entry.

    Therefore, I cannot provide the requested information based on the provided text. The document primarily serves as an FDA clearance letter, not a technical report detailing the device's performance study.

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