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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, T Lymphocyte Surface Marker
510(k) Number K842218
Device Name ANTI-LEU-4 FITC LYSIN C BUFFER
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
WASHINGTON,  DC  20006
Applicant Contact RUSSELL J ARNSBERGE
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
WASHINGTON,  DC  20006
Correspondent Contact RUSSELL J ARNSBERGE
Regulation Number864.5220
Classification Product Code
LIZ  
Date Received06/04/1984
Decision Date 12/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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