Bayer Diagnostics Corp.

FDA 510(k) & PMA Approved Devices — 32 products

Total Devices32

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K033379	BAYER SPECIAL CHEMISTRY CONTROLS	JJY	2003-12-19	View
510(k)	K033380	BAYER SPECIAL CHEMISTRY CALIBRATORS	JIX	2003-12-16	View
510(k)	K033007	BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM	KXT	2003-11-14	View
510(k)	K031857	ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY	DEM	2003-09-04	View
510(k)	K022096	URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	KNK	2003-03-18	View
510(k)	K030452	BAYER LIGAND PLUS 1, 2, 3 CONTROLS	JJY	2003-03-03	View
510(k)	K023840	ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650	CKB	2003-01-07	View
510(k)	K023841	AMMONIA ASSAY FOR THE ADVIA 1650	JIF	2002-12-24	View
510(k)	K022177	PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	LTJ	2002-12-17	View
510(k)	K022329	CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM	LTK	2002-11-27	View
510(k)	K023184	ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM	DIC	2002-11-18	View
510(k)	K022178	CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	MOI	2002-11-12	View
510(k)	K022668	ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD	GKZ	2002-10-15	View
510(k)	K020807	AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	LOJ	2002-10-01	View
510(k)	K022968	ADVIA TESTPOINT CSF CONTROL	JPK	2002-09-24	View
510(k)	K022331	ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD	GKL	2002-09-11	View
510(k)	K020616	BAYER RAPIDPOINT 405 SYSTEM	GKR	2002-07-17	View
510(k)	K021151	AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	JIF	2002-07-13	View
510(k)	K020794	SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	DKJ	2002-07-11	View
510(k)	K020792	ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	LDP	2002-07-11	View