FDA Product Code
FDA Product Code CZJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K092450 | HUMAN IGD KIT FOR USE ON SPAPLUS | The Binding Site | 2009-12-28 | Traditional | PDF ↗ |
| K051299 | IGD DIAGNOSTIC TEST KITS | The Binding Site, Ltd. | 2005-11-23 | Traditional | PDF ↗ |
| K002561 | SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT | The Binding Site, Ltd. | 2000-10-26 | Traditional | PDF ↗ |
| K913671 | HUMAN IGD IMMUNOLOGICAL NL TEST KIT | The Binding Site, Ltd. | 1991-12-02 | Traditional | PDF ↗ |
| K883001 | QM300 CALIBRATOR D PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-09-22 | Traditional | PDF ↗ |
| K872834 | TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 | Helena Laboratories | 1987-08-12 | Traditional | PDF ↗ |
| K831956 | DETERM. SIZE 72 RADIAL-HUMAN IGD | Kent Laboratories, Inc. | 1983-07-18 | Traditional | PDF ↗ |
| K772327 | LAS-R HUMAN IGD TEST | Hyland Therapeutic Div., Travenol Laboratories | 1978-02-28 | Traditional | PDF ↗ |
Product code CZJ · Class II · Immunology. Data: openFDA.