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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cells, Animal And Human, Cultured
510(k) Number K780869
Device Name CELL CULTURE LINES
Applicant
Bioassay Systems Research Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Bioassay Systems Research Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.2280
Classification Product Code
KIR  
Date Received05/30/1978
Decision Date 08/14/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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