FDA Product Code
FDA Product Code NJW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.1860
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220163 | Her-2, ER, PR IHControls | Boston Cell Standards, Inc. | 2022-08-15 | Traditional | PDF ↗ |
| K023335 | QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) | Qc Sciences, LLC | 2003-06-18 | Traditional | PDF ↗ |
Product code NJW · Class II · Hematology. Data: openFDA.