510(k) K850990

HFF GENCELLS by Bioassay Systems Research Corp. — Product Code KIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1985
Date Received
March 11, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media And Components, Synthetic Cell And Tissue Culture
Device Class
Class I
Regulation Number
864.2220
Review Panel
PA
Submission Type