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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 K000897
Device Name CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE
Applicant
BD Biosciences
2350 QUME DR.
SAN JOSE,  CA  95131 -1807
Applicant Contact CINDY MORROW
Correspondent
BD Biosciences
2350 QUME DR.
SAN JOSE,  CA  95131 -1807
Correspondent Contact CINDY MORROW
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received03/21/2000
Decision Date 05/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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