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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
Applicant Contact CINDY MORROW
Correspondent
Bd Biosciences
2350 Qume Dr.
San Jose,  CA  95131
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
Predetermined Change
Control Plan Authorized		 No
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