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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Control
510(k) Number K063823
Device Name COAGUCHEK XS PT CONTROLS
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact THERESA AMBROSE BUSH
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact THERESA AMBROSE BUSH
Regulation Number864.5425
Classification Product Code
GGN  
Date Received12/26/2006
Decision Date 01/29/2007
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
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