CZJ
8 FDA 510(k) clearances · Product code
70 daysmedian time to decision
189 days90th percentile
8clearances measured
FDA profile
- Official device name
- Igd, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| HUMAN IGD KIT FOR USE ON SPAPLUS (K092450) | The Binding Site | 2009-12-28 |
| IGD DIAGNOSTIC TEST KITS (K051299) | The Binding Site, Ltd. | 2005-11-23 |
| SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT (K002561) | The Binding Site, Ltd. | 2000-10-26 |
| HUMAN IGD IMMUNOLOGICAL NL TEST KIT (K913671) | The Binding Site, Ltd. | 1991-12-02 |
| QM300 CALIBRATOR D PACK (K883001) | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-09-22 |
| TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 (K872834) | Helena Laboratories | 1987-08-12 |
| DETERM. SIZE 72 RADIAL-HUMAN IGD (K831956) | Kent Laboratories, Inc. | 1983-07-18 |
| LAS-R HUMAN IGD TEST (K772327) | Hyland Therapeutic Div., Travenol Laboratories | 1978-02-28 |
Track CZJ automatically
Every clearance here is in the API, with alerts when new ones post.