MDA B.30


Device Classification Name

system, multipurpose for in vitro coagulation studies

510(k) Number K050513
Device Name MDA B.30
Applicant
BIOMERIEUX, INC.
100 rodolphe st
durham, 
NC 
27712

Applicant Contact jocelyn jennings
Correspondent
BIOMERIEUX, INC.
100 rodolphe st
durham, 
NC 
27712

Correspodent Contact jocelyn jennings
Regulation Number 864.5425
Classification Product Code
JPA  
Date Received 03/01/2005
Decision Date 04/01/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No