Medical Device Manufacturer · US , Lake Success , NY

Olympus America, Inc. - FDA 510(k) Cleared Devices

149 submissions · 149 cleared · Since 1994

149

Total

149

Cleared

0

Denied

FDA 510(k) Regulatory Record - Olympus America, Inc. Chemistry ✕

34 devices

1-12 of 34

Cleared Apr 06, 2007

OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

Chemistry · 193d

Cleared Mar 23, 2007

OLYMPUS TRIGLYCERIDE TEST SYSTEM

Chemistry · 91d

Cleared Nov 29, 2006

OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM

Chemistry · 90d

Cleared Oct 05, 2006

OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117

Chemistry · 120d

Cleared Aug 22, 2005

OLYMPUS CRP LATEX REAGENT, OSR6199

Chemistry · 69d

Cleared Jan 31, 2005

OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071

Chemistry · 47d

Cleared Dec 23, 2004

OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279

Chemistry · 35d

Cleared Dec 03, 2004

OLYMPUS LACTATE, OSR6193

Chemistry · 91d

Cleared Aug 19, 2004

OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT

Chemistry · 62d

Cleared Jul 16, 2004

OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524

Chemistry · 14d

Cleared Apr 08, 2004

OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL...

Chemistry · 22d

Cleared Mar 10, 2004

OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296

Chemistry · 15d