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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator For Red-Cell And White-Cell Counting
510(k) Number K854823
Device Name CBC-CAL/MULTIPLE
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 Number864.8185
Classification Product Code
KSA  
Date Received12/03/1985
Decision Date 02/13/1986
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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