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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K050352
Device Name IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT
Applicant
Ameritek Research, LLC
15205 3rd Dr. SE
Mill Creek,  WA  98012
Applicant Contact KUD CHAIANG YEE
Correspondent
Ameritek Research, LLC
15205 3rd Dr. SE
Mill Creek,  WA  98012
Correspondent Contact KUD CHAIANG YEE
Regulation Number866.2660
Classification Product Code
JTO  
Subsequent Product Codes
JIO   JIR   JMT   LJX   LNW  
Date Received02/11/2005
Decision Date 09/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Clinical Chemistry
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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