LumiQuick Diagnostics, Inc. - Feb. 24, 2014
Issue Date
Feb 24, 2014
Region
Pacific
Category
Device
$117.00
Contact Name
Chang "Charles" F. Yu
Contact Title
President
Address 1
2946 Scott Blvd.
City
Santa Clara
State
CA
Zip/Postal Code
95054-3312
Country
United States
Inspection Range
Feb 04, 2014 - Feb 24, 2014
Pages
5
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Timothy C. Grome