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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 K851843
Device Name OSMOCEL 3
Applicant
Hematology Marketing Assoc.
P.O. Box 6756
Concord,  CA  94524
Applicant Contact JAMES LAPICOLA
Correspondent
Hematology Marketing Assoc.
P.O. Box 6756
Concord,  CA  94524
Correspondent Contact JAMES LAPICOLA
Regulation Number864.8200
Classification Product Code
GIF  
Date Received04/26/1985
Decision Date 07/30/1985
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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