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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 K881161
Device Name TECH-CAL(TM)/MULTIPLE
Applicant
R & D SYSTEMS, INC.
614 MCKINLEY PL., N.E.
MINNEAPOLIS,  MN  55413
Applicant Contact KAREN VISKOCHIL
Correspondent
R & D SYSTEMS, INC.
614 MCKINLEY PL., N.E.
MINNEAPOLIS,  MN  55413
Correspondent Contact KAREN VISKOCHIL
Regulation Number864.8185
Classification Product Code
KSA  
Date Received03/18/1988
Decision Date 05/02/1988
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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