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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 K072920
Device Name HANDHELD BASE UNIT
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Applicant Contact JASON FISHER
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Correspondent Contact JASON FISHER
Regulation Number864.7750
Classification Product Code
GJS  
Date Received10/15/2007
Decision Date 01/31/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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