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 In this section:

                Tests Used In Clinical Care

Tests Used In Clinical Care

                        Safety Issue on Magellan Diagnostics LeadCare Testing Systems Home
          Medical Devices
          Products and Medical Procedures
          In Vitro Diagnostics
          Tests Used In Clinical Care
          Find All In Vitro Diagnostic Products and Decision Summaries Since November 2003Tests Used In Clinical Care Find All In Vitro Diagnostic Products and Decision Summaries Since November 2003
  
  	
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    PrintThis database search obtains information on all In Vitro Diagnostic Devices cleared or approved since November 2003. Many of the products in this database have Decision Summaries, from which you can get the information OIVD used to clear or approve the products.
Each Decision Summary contains:
a review of the data submitted by an applicant to support a PMA or 510(k) application, and
    FDA’s justification in approving or clearing the product.
    You can use Decision Summaries to:
    see what types of clinical studies other applicants conducted so that you can conduct similar studies
    learn how FDA reviewed an applicant’s data to grant approval or substantial equivalence
    find out how thoroughly an applicant studied a particular product before it was submitted to FDADecision Summaries are attached to entries in FDA’s **In Vitro Diagnostic Product Database**. To find a Decision Summary for a particular product,
go to link nearby for FDA’s **In Vitro Diagnostic Product Database**
    enter a search term (for example the type of test, name, company, or other key word) in the blank space
    click on “Search”
    review the listing of products that match your search term
    select a product from the list
    scroll through the Device Summary Information for the entry marked Decision SummaryIn Vitro Diagnostic Product DatabaseIn Vitro Diagnostic Product Database

                                                                                  Content current as of:
      12/28/2017Tests Used In Clinical Care

          
                        Safety Issue on Magellan Diagnostics LeadCare Testing Systems
 
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