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
|
|
Correspondent Contact |
STEPHANIE G DONNELLY |
Regulation Number | 862.1110
|
Classification Product Code |
|
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
|
|
|