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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 K810040
Device Name ACRIDINE ORANGE STAIN
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
WASHINGTON,  DC  20006
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
WASHINGTON,  DC  20006
Regulation Number864.1850
Classification Product Code
IDC  
Date Received01/09/1981
Decision Date 02/12/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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