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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K021190
Device Name PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact JENNIFER TRIBBETT
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact JENNIFER TRIBBETT
Regulation Number864.7750
Classification Product Code
GJS  
Date Received04/15/2002
Decision Date 10/25/2002
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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