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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flow Cytometric Reagents And Accessories.
510(k) Number K170974
Device Name BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK
Applicant
Becton, Dickinson and Company
2350 Qume Dr.
San Jose,  CA  95131
Applicant Contact Li Zhou
Correspondent
Becton, Dickinson and Company
2350 Qume Dr.
San Jose,  CA  95131
Correspondent Contact Li Zhou
Regulation Number864.5220
Classification Product Code
OYE  
Date Received04/03/2017
Decision Date 07/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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