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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 K983892
Device Name COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P
Applicant
Roche Diagnostics/Boehringer Mannheim GmbH
9115 Hague Rd.
Indianapolis,  IN  46256
Applicant Contact LUANN OCHS
Correspondent
Roche Diagnostics/Boehringer Mannheim GmbH
9115 Hague Rd.
Indianapolis,  IN  46256
Correspondent Contact LUANN OCHS
Regulation Number864.5425
Classification Product Code
JPA  
Date Received11/03/1998
Decision Date 04/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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