Olympus America, Inc.

FDA 510(k) & PMA Approved Devices — 149 products

Total Devices149

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K111788	ENDOEYE HD II	HET	2012-01-13	View
510(k)	K081615	OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN	DHX	2009-03-18	View
510(k)	K073489	OLYMPUS IGA REAGENT	CFN	2008-02-11	View
510(k)	K073487	OLYMPUS IGM REAGENT	CFN	2008-02-11	View
510(k)	K073490	OLYMPUS IGG REAGENT	CFN	2008-02-11	View
510(k)	K062862	OLYMPUS URIC ACID REAGENT, MODEL OSR6X98	KNK	2007-04-06	View
510(k)	K063804	OLYMPUS TRIGLYCERIDE TEST SYSTEM	CDT	2007-03-23	View
510(k)	K061499	OSFERION	MQV	2007-01-26	View
510(k)	K062581	OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM	JLW	2006-11-29	View
510(k)	K061575	OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117	CJY	2006-10-05	View
510(k)	K060201	OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.	DHR	2006-06-06	View
510(k)	K051564	OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH	NQD	2005-08-22	View
510(k)	K051541	GF-UE160-AL5 ULTRASOUND ENDOSCOPE	FDF	2005-07-01	View
510(k)	K043460	OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071	JIX	2005-01-31	View
510(k)	K043202	OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279	CGS	2004-12-23	View
510(k)	K042406	OLYMPUS LACTATE, OSR6193	JIT	2004-12-03	View
510(k)	K041668	OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT	NQD	2004-08-19	View
510(k)	K041793	OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524	JMO	2004-07-16	View
510(k)	K040692	OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023	JIT	2004-04-08	View
510(k)	K040471	OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024	JIT	2004-03-10	View