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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diluent, Blood Cell
510(k) Number K840041
Device Name SDI PREPAX DILUKIT HW
Applicant
Scientific Distributors, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Scientific Distributors, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.8200
Classification Product Code
GIF  
Date Received01/06/1984
Decision Date 03/05/1984
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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