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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stains, hematology
510(k) Number K843619
Device Name RETIC-SET
Applicant
R & D SYSTEMS, INC.
614 MCKINLEY PL., N.E.
MINNEAPOLIS,  MN  55413
Applicant Contact DALE A CHRISTENSEN
Correspondent
R & D SYSTEMS, INC.
614 MCKINLEY PL., N.E.
MINNEAPOLIS,  MN  55413
Correspondent Contact DALE A CHRISTENSEN
Regulation Number864.1850
Classification Product Code
KQC  
Date Received09/14/1984
Decision Date 10/30/1984
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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