De Novo Software - July 9, 2014
Issue Date
Jul 09, 2014
Region
Pacific
Category
Device
$117.00
Contact Name
David J. Novo
Contact Title
President
Address 1
3250 Wilshire Blvd.
Address 2
Suite 803
City
Los Angeles
State
CA
Zip/Postal Code
90010-1510
Country
United States
Inspection Range
Jul 08, 2014 - Jul 09, 2014
Pages
2
First Observation
Specifically, the design controls used to develop the FCS Express flow cytometer software did not include an established design plan or an established design review procedure.
Investigator(s): James R. Fleckenstein