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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 K050243
Device Name IMMEDIA PROTHROMBIN TIME SYSTEM
Applicant
Farallon Medial, Inc.
3521 Investement Blvd.
Suite 1
Hayward,  CA  94545
Applicant Contact JAMES MCKINLEY
Correspondent
Farallon Medial, Inc.
3521 Investement Blvd.
Suite 1
Hayward,  CA  94545
Correspondent Contact JAMES MCKINLEY
Regulation Number864.5425
Classification Product Code
JPA  
Date Received02/02/2005
Decision Date 06/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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