JQG
5 FDA 510(k) clearances · Product code
38 daysmedian time to decision
72 days90th percentile
5clearances measured
FDA profile
- Official device name
- Radiometric, Fe59, Iron Binding Capacity
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1415
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| COMBO-FER IRON DIAGNOSTIC (K811954) | Immuno Assay Corp. | 1981-07-27 |
| FERRITIRON KIT CAT. #RP-1100 (K800710) | Ria Products, Inc. | 1980-05-14 |
| FERRO-QUANT TM FE 59 TEST KIT (K800868) | Mallinckrodt Critical Care | 1980-04-29 |
| SPINSEP-FE59 (K790133) | Nuclear Diagnostics, Inc. | 1979-03-02 |
| TOTAL IRON BINDING CAPACITY (K780412) | Diagnostic Corp. of America | 1978-05-26 |
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Every clearance here is in the API, with alerts when new ones post.