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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Auramine O
510(k) Number K853081
Device Name AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET
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 Number864.1850
Classification Product Code
KJK  
Date Received07/23/1985
Decision Date 08/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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