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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 cell indices
510(k) Number K912357
Device Name 3K-CAL HEMATOLOGY CALIBRATOR/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 Number864.8150
Classification Product Code
KRX  
Date Received05/28/1991
Decision Date 07/09/1991
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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