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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 K994349
Device Name COAGUCHEK S SYSTEM, MODEL 2138280
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50416
Indianapolis,  IN  46250
Applicant Contact JENNIFER TRIBBETT
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50416
Indianapolis,  IN  46250
Correspondent Contact JENNIFER TRIBBETT
Regulation Number864.5425
Classification Product Code
JPA  
Date Received12/23/1999
Decision Date 09/06/2000
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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