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