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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
Recalls CDRH Recalls
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