CZN
7 FDA 510(k) clearances · Product code
35 daysmedian time to decision
123 days90th percentile
7clearances measured
FDA profile
- Official device name
- Iga, Fitc, 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 |
|---|---|---|
| TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER (K891683) | Helena Laboratories | 1989-04-12 |
| QUANTIMETRIC PLUS C3 REAGENT KIT (K855011) | Kallestad Laboratories, Inc. | 1986-02-26 |
| OPTIMATE IGA TEST (K841815) | Miles Laboratories, Inc. | 1984-06-01 |
| FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS (K832262) | Gelco Diagnostics, Inc. | 1983-10-31 |
| GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC (K832257) | Gelco Diagnostics, Inc. | 1983-10-28 |
| RABBIT ANTISERUM TO HUMAN IGA (K831909) | Dako Corp. | 1983-07-18 |
| FIAX IGA TEST KIT (K831607) | Intl. Diagnostic Technology | 1983-06-22 |
Track CZN automatically
Every clearance here is in the API, with alerts when new ones post.