Nanoentek USA, Inc. is one of 13015 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Nanoentek USA, Inc. - FDA 510(k) Cleared Devices
Recent clearances: FREND PSA PLUS (reagent cartridge), FREND Vitamin D Test System, FREND Testosterone Test System
5
Total
5
Cleared
0
Denied
Nanoentek USA, Inc. has 5 FDA 510(k) cleared medical devices. Based in Oxford, US.
Historical record: 5 cleared submissions from 2014 to 2017. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Nanoentek USA, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Newworld Regulatory Solutions, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Nanoentek USA, Inc.
5 devices
Cleared
May 17, 2017
FREND PSA PLUS (reagent cartridge)
Immunology
266d
Cleared
Jan 12, 2017
FREND Vitamin D Test System
Chemistry
104d
Cleared
Oct 14, 2016
FREND Testosterone Test System
Chemistry
304d
Cleared
Feb 17, 2016
FREND™ Free T4 Test System
Chemistry
175d
Cleared
Mar 14, 2014
FREND TSH (REAGENT CARTRIDGE)
Chemistry
260d