OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181


Device Classification Name

diazo colorimetry, bilirubin

510(k) Number K080435
Device Name OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
Applicant
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
3500 corporate pkway
center valley, 
PA 
18034

Applicant Contact stephanie g donnelly
Correspondent
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
3500 corporate pkway
center valley, 
PA 
18034

Correspodent Contact stephanie g donnelly
Regulation Number 862.1110
Classification Product Code
CIG  
Date Received 02/19/2008
Decision Date 09/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No