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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acridine Orange
510(k) Number K853187
Device Name ACRIDINE ORANGE FLUORESCENT STAIN
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
IDC  
Date Received07/30/1985
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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