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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media And Components, Synthetic Cell And Tissue Culture
510(k) Number K850990
Device Name HFF GENCELLS
Applicant
Bioassay Systems Research Corp.
225 Wildwood Ave.
Woburn,  MA  01801
Applicant Contact MARK P BEAR
Correspondent
Bioassay Systems Research Corp.
225 Wildwood Ave.
Woburn,  MA  01801
Correspondent Contact MARK P BEAR
Regulation Number864.2220
Classification Product Code
KIT  
Date Received03/11/1985
Decision Date 04/12/1985
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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