CELLSEARCH EPITHELIAL CELL CONTROL KIT
FDA 510(k) clearance K040898 · decided 2004-06-28
Clearance details
- K-number
- K040898
- Device name
- CELLSEARCH EPITHELIAL CELL CONTROL KIT
- Applicant
- Veridex, LLC
- Decision
- Substantially Equivalent
- Date received
- 2004-04-06
- Decision date
- 2004-06-28
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- NRS
- Device class
- 2
- Regulation number
- 864.8625
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Raritan, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Veridex
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003 recall (Z-1472-2011) | Veridex, LLC | 2011-03-01 |