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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K973957
Device Name DBEST ONE-STEP HCG SERUM/URINE TEST
Applicant
Ameritek, Inc.
7030 35th Ave., NE
Seattle,  WA  98115
Applicant Contact K C YEE
Correspondent
Ameritek, Inc.
7030 35th Ave., NE
Seattle,  WA  98115
Correspondent Contact K C YEE
Regulation Number862.1155
Classification Product Code
JHI  
Date Received10/16/1997
Decision Date 12/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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