The following data is part of a premarket notification filed by Immunicon Corp. with the FDA for Immunicon Celltracks Autoprep System.
| Device ID | K040077 |
| 510k Number | K040077 |
| Device Name: | IMMUNICON CELLTRACKS AUTOPREP SYSTEM |
| Classification | Apparatus, Automated Blood Cell Diluting |
| Applicant | IMMUNICON CORP. 3401 MASONS MILL RD. Huntingdon Valley, PA 19006 -3574 |
| Contact | Peter J Scott |
| Correspondent | Peter J Scott IMMUNICON CORP. 3401 MASONS MILL RD. Huntingdon Valley, PA 19006 -3574 |
| Product Code | GKH |
| CFR Regulation Number | 864.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-14 |
| Decision Date | 2004-03-12 |
| Summary: | summary |