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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 K973483
Device Name FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET
Applicant
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
2350 QUME DR.
SAN JOSE,  CA  95131 -1807
Applicant Contact CINDY MORROW
Correspondent
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
2350 QUME DR.
SAN JOSE,  CA  95131 -1807
Correspondent Contact CINDY MORROW
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received09/15/1997
Decision Date 02/17/1998
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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