Seradyn, Inc.

FDA 510(k) & PMA Approved Devices — 28 products

Total Devices28

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K070645	SERADYN QMS TOPIRAMATE	NWM	2007-05-17	View
510(k)	K062966	QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS	ORH	2007-01-12	View
510(k)	K062204	ARCHITECT CORTISOL ASSAY	JFT	2006-09-22	View
510(k)	K060998	QMS TOBRAMYCIN	LCR	2006-07-21	View
510(k)	K060709	MULTIGENT GENTAMICIN	LCD	2006-06-15	View
510(k)	K052826	QMS QUINIDINE. QMS QUINIDINE CALIBRATORS	LBZ	2005-12-23	View
510(k)	K051211	QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS	NWM	2005-11-18	View
510(k)	K052815	QMS AMIKACIN REAGENTS	KLQ	2005-11-01	View
510(k)	K050419	QMS VANCOMYCIN	LEH	2005-04-01	View
510(k)	K042307	ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)	JIT	2004-11-03	View
510(k)	K033674	MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS	LCP	2004-02-09	View
510(k)	K981496	COLOR-SLIDE RF	DHR	1998-06-15	View
510(k)	K952544	COLORSLIDER RUBELLA	LQN	1996-01-17	View
510(k)	K942991	QMS THEOPHYLLINE CS	LGS	1994-09-09	View
510(k)	K940374	QMS CARBAMAZEPINE ASSAY	KLT	1994-06-02	View
510(k)	K940376	QMS GENTAMICIN ASSAY	LCD	1994-06-02	View
510(k)	K936208	VALPROIC ACID	LEG	1994-03-11	View
510(k)	K934388	QMS PHENOBARBITAL	LFN	1994-02-25	View
510(k)	K925326	ELECTROPHORESIS CONTROL LEVEL 1	JJY	1993-03-26	View
510(k)	K924186	LPIA-FERRITIN ASSAY	DEF	1992-12-23	View