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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Quality Control For Blood Banking Reagents
510(k) Number K790249
Device Name TEST CELLS
Applicant
Hyland Therapeutic Div., Travenol Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hyland Therapeutic Div., Travenol Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.9650
Classification Product Code
KSF  
Date Received02/08/1979
Decision Date 05/16/1979
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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