The following data is part of a premarket notification filed by Icn Biomedicals, Inc. with the FDA for Lympho Sep(tm).
| Device ID | K902445 |
| 510k Number | K902445 |
| Device Name: | LYMPHO SEP(TM) |
| Classification | Lymphocyte Separation Medium |
| Applicant | ICN BIOMEDICALS, INC. 3300 HYLAND AVE. Costa Mesa, CA 92626 |
| Contact | L. S Sudbury |
| Correspondent | L. S Sudbury ICN BIOMEDICALS, INC. 3300 HYLAND AVE. Costa Mesa, CA 92626 |
| Product Code | JCF |
| CFR Regulation Number | 864.8500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-01 |
| Decision Date | 1990-08-22 |