NJW
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Control Material, Her-2/Neu, Immunohistochemistry
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.1860
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
- FDA definition
- Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Her-2, ER, PR IHControls (K220163) | Boston Cell Standards, Inc. | 2022-08-15 |
| QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) (K023335) | Qc Sciences, LLC | 2003-06-18 |
Track NJW automatically
Every clearance here is in the API, with alerts when new ones post.