OLYMPUS TOTAL BHCG TEST SYSTEN


Device Classification Name

system, test, human chorionic gonadotropin

510(k) Number K080094
Device Name OLYMPUS TOTAL BHCG TEST SYSTEN
Applicant
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
3131 west royal lane
irving, 
TX 
75063

Applicant Contact stephanie donnelly
Correspondent
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
3131 west royal lane
irving, 
TX 
75063

Correspodent Contact stephanie donnelly
Regulation Number 862.1155
Classification Product Code
DHA  
Subsequent Product Codes
JIT   JJX  
Date Received 01/14/2008
Decision Date 09/03/2008
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