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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Opiates
510(k) Number K983190
Device Name DBEST OPIATES TEST KIT
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 Number862.3650
Classification Product Code
DJG  
Date Received09/11/1998
Decision Date 11/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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