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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. NE
Minneapolis,  MN  55413
Applicant Contact DALE A CHRISTENSEN
Correspondent
R&D Systems, Inc.
614 Mckinley Pl. NE
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
Predetermined Change
Control Plan Authorized		 No
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