Advandx, Inc.

FDA 510(k) & PMA Approved Devices — 20 products

Total Devices20

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K123418	GRAM-NEGATIVE QUICKFISH BC	JSS	2013-07-21	View
510(k)	K121991	ENTEROCOCCUS QUICKFISH BC	OAH	2013-01-07	View
510(k)	K113371	STAPHYLOCOCCUS QUICKFISH BC	NXX	2012-04-03	View
510(k)	K101558	GNR TRAFFIC LIGHT PNA FISH	JSS	2010-12-16	View
510(k)	K093024	YEAST TRAFFIC LIGHT PNA FISH	NZS	2010-07-15	View
510(k)	K092784	C. ALBICANS/C. GLABRATA PNA FISH	NZS	2010-03-12	View
510(k)	K092655	C. ALBICANS PNA FISH	NZS	2010-01-19	View
510(k)	K092236	E.COLI/P. AERUGINOSA PNA FISH	JSS	2009-12-16	View
510(k)	K092166	S. AUREUS/CNS PNA FISH, MODEL KT005	NXX	2009-11-23	View
510(k)	K092393	EK/P. AERUGINOSA PNA FISH	JSS	2009-09-01	View
510(k)	K091827	S. AUREUS PNA FISH	NXX	2009-08-18	View
510(k)	K083074	AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT	OAH	2009-07-24	View
510(k)	K082068	E. COLI PNA FISH	JSS	2009-06-25	View
510(k)	K082612	GBS PNA FISH	OAH	2009-05-05	View
510(k)	K081433	EK/P. AERUGINOSA PNA FISH	JSS	2009-03-26	View
510(k)	K081309	E.COLI/P. AERUGINOSA PNA FISH	JSS	2008-12-19	View
510(k)	K080719	YEAST TRAFFIC LIGHT PNA FISH	JXB	2008-09-12	View
510(k)	K063127	ENTEROCOCCUS FAECALIS PNA FISH	OAH	2006-12-22	View
510(k)	K062461	C. ALBICANS PNA FISH	JXB	2006-10-25	View
510(k)	K060099	S. AUREUS PNA FISH	NXX	2006-05-08	View