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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K970836
Device Name TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS
Applicant
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
2350 QUME DR.
SAN JOSE,  CA  95131 -1807
Applicant Contact ANNA LONGWELL
Correspondent
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
2350 QUME DR.
SAN JOSE,  CA  95131 -1807
Correspondent Contact ANNA LONGWELL
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/24/1997
Decision Date 08/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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