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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K082091
Device Name TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00
Applicant
Reametrix, Inc.
1585 Industrial Rd.
San Carlos,  CA  94070
Applicant Contact STEVE KUNITAKE
Correspondent
Reametrix, Inc.
1585 Industrial Rd.
San Carlos,  CA  94070
Correspondent Contact STEVE KUNITAKE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received07/24/2008
Decision Date 04/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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