July 2015

kBLASTER update July 2015 #2: 510(k) search for predicates and successful 510(k) clearance strategy

The kBLASTER database has been updated today with FDA 510(k) clearances from June 2015 and FDA 510(k) splash pages for 510(k)s clearances in July 2015. If you have Saved Searches in your kBLASTER account that meet the parameters of today's imports into the kBLASTER database, you will see blue notification flags in your active kBLASTER account on those Saved Searches, as well as Alert email(s).  

With more than 61,000 510(k)...

kBLASTER update July 2015: 510(k) search for predicates and successful 510(k) clearance strategy

The kBLASTER database has been updated today with FDA 510(k) clearances from June 2015 and FDA 510(k) splash pages for 510(k)s clearances in July 2015. If you have Saved Searches in your kBLASTER account that meet the parameters of today's imports into the kBLASTER database, you will see blue notification flags in your active kBLASTER account on those Saved Searches, as well as Alert email(s).  

With more than 61,000 510(k)...

Theranos receives FDA 510(k) clearance and review and validation of revolutionary finger stick technology, test, and associated test system

by Theranos

PALO ALTO, Cal. (July 2, 2015) – Theranos, Inc. (Theranos) today announced that it has received the U.S. Food and Drug Administration’s (FDA) 510(k) clearance of its test system and test for herpes simplex 1 virus IgG. The FDA’s decision provides independent validation of Theranos’ patented finger stick and venous blood testing technology and the ground breaking Theranos System upon which the HSV-1 IgG test is run, as...