The following data is part of a premarket notification filed by Veridex, Llc with the FDA for Modification To Cellsearch Circulating Tumor Cell Kit.
| Device ID | K052191 |
| 510k Number | K052191 |
| Device Name: | MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT |
| Classification | System, Immunomagnetic, Circulating Cancer Cell, Enumeration |
| Applicant | VERIDEX, LLC 1001 US HIGHWAY 202 NORTH Raritan, NJ 08869 -0606 |
| Contact | Debra J Rasmussen |
| Correspondent | Debra J Rasmussen VERIDEX, LLC 1001 US HIGHWAY 202 NORTH Raritan, NJ 08869 -0606 |
| Product Code | NQI |
| CFR Regulation Number | 866.6020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-11 |
| Decision Date | 2005-10-27 |