FDA Product Code
FDA Product Code DGE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K915838 | OPUS FERRITIN TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1992-03-18 | Traditional | PDF ↗ |
| K871972 | STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY | American Dade | 1987-07-21 | Traditional | PDF ↗ |
Product code DGE · Class II · Immunology. Data: openFDA.