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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 K851320
Device Name SDI PREPAX DILUKIT M.
Applicant
Scientific Distributors, Inc.
Bldg. 24 Endicott St.
Norwood,  MA  02062
Applicant Contact MICHAEL J BOYLE
Correspondent
Scientific Distributors, Inc.
Bldg. 24 Endicott St.
Norwood,  MA  02062
Correspondent Contact MICHAEL J BOYLE
Regulation Number864.8200
Classification Product Code
GIF  
Date Received04/02/1985
Decision Date 07/05/1985
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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