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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lymphocyte Separation Medium
510(k) Number K873185
Device Name DYNABEADS HLA CELL PREP II ISOLATION PRODUCT
Applicant
Dynal Biotech, Inc.
45 N. Station Plz.
Great Neck,  NY  11021
Applicant Contact BARBARA A SAWITSKY
Correspondent
Dynal Biotech, Inc.
45 N. Station Plz.
Great Neck,  NY  11021
Correspondent Contact BARBARA A SAWITSKY
Regulation Number864.8500
Classification Product Code
JCF  
Date Received08/12/1987
Decision Date 11/04/1987
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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