FDA Product Code
FDA Product Code CHN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5210
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K091741 | TINA-QUANT CERULOPLASMIN | Roche Diagnostics | 2010-03-18 | Traditional | PDF ↗ |
| K063655 | DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH | Dade Behring, Inc. | 2007-02-15 | Traditional | PDF ↗ |
| K062114 | CERULOPLASMIN, MODEL 2055953 | Roche Diagnostics Corp. | 2007-01-31 | Traditional | PDF ↗ |
Product code CHN · Class II · Immunology. Data: openFDA.