The following data is part of a premarket notification filed by Veridex, Llc with the FDA for Cellsearch Epithelial Cell Control Kit.
| Device ID | K040898 |
| 510k Number | K040898 |
| Device Name: | CELLSEARCH EPITHELIAL CELL CONTROL KIT |
| Classification | Control Material, Blood Circulating Epithelial Cancer Cell |
| Applicant | VERIDEX, LLC 1001 US HWY 202 Raritan, NJ 08869 -0606 |
| Contact | Debra J Rasmussen |
| Correspondent | Debra J Rasmussen VERIDEX, LLC 1001 US HWY 202 Raritan, NJ 08869 -0606 |
| Product Code | NRS |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-06 |
| Decision Date | 2004-06-28 |
| Summary: | summary |