FDA Product Code
FDA Product Code NID — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5220
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K101911 | IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY | Cylex, Inc. | 2010-10-18 | Special | PDF ↗ |
| K013169 | IMMUNE CELL FUNCTION ASSAY | Cylex, Inc. | 2002-04-02 | Traditional | PDF ↗ |
Product code NID · Class II · Hematology. Data: openFDA.