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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact JOCELYN JENNINGS
Regulation Number864.5425
Classification Product Code
JPA  
Date Received03/01/2005
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
Predetermined Change
Control Plan Authorized		 No
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