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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 K982231
Device Name STATUSFLOW
Applicant
R&D Systems, Inc.
614 Mckinley Pl NE
Minneapolis,  MN  55413
Applicant Contact KENNETH T EDDS
Correspondent
R&D Systems, Inc.
614 Mckinley Pl NE
Minneapolis,  MN  55413
Correspondent Contact KENNETH T EDDS
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received06/25/1998
Decision Date 07/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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