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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Staphylococcus Aureus
510(k) Number K852997
Device Name RAPI - STAPH
Applicant
Advanced Medical Technology, Inc.
Suite 502, Perimeter Park
3351 Wrightsboro, Rd.
Augusta,  GA  30909
Applicant Contact DAVID A WALL
Correspondent
Advanced Medical Technology, Inc.
Suite 502, Perimeter Park
3351 Wrightsboro, Rd.
Augusta,  GA  30909
Correspondent Contact DAVID A WALL
Regulation Number866.2660
Classification Product Code
JWX  
Date Received07/15/1985
Decision Date 08/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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