510(k) K843864

ULTRACLONE ECL-01-1400 CELL LINE by Earl-Clay Laboratories, Inc. — Product Code KIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1984
Date Received
October 2, 1984
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