The following data is part of a premarket notification filed by Immunicon Corp. with the FDA for Immunicon Cellsave Preservative Tube.
| Device ID | K030596 |
| 510k Number | K030596 |
| Device Name: | IMMUNICON CELLSAVE PRESERVATIVE TUBE |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | IMMUNICON CORP. 3401 MASONS MILL RD. STE 100 Huntingdon Valley, PA 19006 -3574 |
| Contact | Peter Scott |
| Correspondent | Peter Scott IMMUNICON CORP. 3401 MASONS MILL RD. STE 100 Huntingdon Valley, PA 19006 -3574 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-25 |
| Decision Date | 2003-08-08 |
| Summary: | summary |