The following data is part of a premarket notification filed by Immunicon Corp. with the FDA for Celltracka Analyzer Ii.
| Device ID | K050145 |
| 510k Number | K050145 |
| Device Name: | CELLTRACKA ANALYZER II |
| Classification | System, Immunomagnetic, Circulating Cancer Cell, Enumeration |
| 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 | NQI |
| CFR Regulation Number | 866.6020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-24 |
| Decision Date | 2005-03-15 |
| Summary: | summary |