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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 K003991
Device Name CD-CAL PLUS CALIBRATOR
Applicant
R&D Systems, Inc.
614 Mckinley Pl NE
Minneapolis,  MN  55413
Applicant Contact KENNETH T EDDS
Correspondent
R&D Systems, Inc.
614 Mckinley Pl NE
Minneapolis,  MN  55413
Correspondent Contact KENNETH T EDDS
Regulation Number864.8150
Classification Product Code
KRX  
Subsequent Product Codes
KRY   KRZ   KSA  
Date Received12/26/2000
Decision Date 01/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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