The following data is part of a premarket notification filed by Sepratech Corporation C/o Keller And Heckman with the FDA for Sepracell Lymphocyte Separation Medium.
| Device ID | K860354 |
| 510k Number | K860354 |
| Device Name: | SEPRACELL LYMPHOCYTE SEPARATION MEDIUM |
| Classification | Lymphocyte Separation Medium |
| Applicant | SEPRATECH CORPORATION C/O KELLER AND HECKMAN 1150 17TH STREET, N.W. SUITE 1000 Washington, DC 20036 |
| Contact | La Cruz |
| Correspondent | La Cruz SEPRATECH CORPORATION C/O KELLER AND HECKMAN 1150 17TH STREET, N.W. SUITE 1000 Washington, DC 20036 |
| Product Code | JCF |
| CFR Regulation Number | 864.8500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-30 |
| Decision Date | 1986-04-18 |