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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Occult Blood
510(k) Number K071242
Device Name DBEST ONE STEP OCCULT BLOOD TEST KITS
Applicant
Ameritek USA, Inc.
125 130th St. SE
Everett,  WA  98208
Applicant Contact K.C. YEE
Correspondent
Ameritek USA, Inc.
125 130th St. SE
Everett,  WA  98208
Correspondent Contact K.C. YEE
Regulation Number864.6550
Classification Product Code
KHE  
Date Received05/03/2007
Decision Date 03/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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