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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 -0457
Applicant Contact JENNIFER TRIBBETT
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50416
INDIANAPOLIS,  IN  46250 -0457
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
Recalls CDRH Recalls
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