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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
Recalls CDRH Recalls
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