Organon Teknika Corp.

FDA 510(k) & PMA Approved Devices — 130 products

Total Devices130

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K003104	BACT/ALERT CSR	LJF	2000-10-20	View
510(k)	K000492	MDA D-DIMER	DAP	2000-06-07	View
510(k)	K000378	BACT/ALERT MB CULTURE BOTTLE	MDB	2000-03-02	View
510(k)	K994343	BACT/ALERT SV	MDB	2000-02-10	View
510(k)	K993423	BACT/ALERT SA	MDB	1999-12-15	View
510(k)	K993576	BACT/ALERT MP PROCESS BOTTLE	MDB	1999-12-14	View
510(k)	K993421	BACT/ALERT SN	MDB	1999-12-14	View
510(k)	K992432	BACT/ALERT FN	MDB	1999-09-24	View
510(k)	K983762	NUCLISENS CMV PP67	LIN	1999-09-15	View
510(k)	K992400	BACTALERT FA	MDB	1999-09-03	View
510(k)	K992401	BACT/ALERT PF	MDB	1999-09-03	View
510(k)	K992598	TOF-WATCH SX	KOI	1999-08-30	View
510(k)	K992596	TOF-WATCH S	KOI	1999-08-30	View
510(k)	K991101	COAG-A-MATE MAX	GKP	1999-06-01	View
510(k)	K983772	MB/BACT BLOOD CULTURE BOTTLE	MDB	1999-01-13	View
510(k)	K982263	MB/BACT BLOOD CULTURE BOTTLE	MDB	1998-08-18	View
510(k)	K981736	BACT/ALERT 3D MICROBIAL DETECTION SYSTEM	MDB	1998-07-24	View
510(k)	K974776	MDA D-DIMER	DAP	1998-04-16	View
510(k)	K974566	MDA SIMPLASTIN HTF	GJS	1998-02-24	View
510(k)	K972698	TOF-WATCH	KOI	1997-12-16	View