510(k) K902445

LYMPHO SEP(TM) by Icn Biomedicals, Inc. — Product Code JCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1990
Date Received
June 1, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lymphocyte Separation Medium
Device Class
Class I
Regulation Number
864.8500
Review Panel
HE
Submission Type