JQG — Radiometric, Fe59, Iron Binding Capacity Class I
FDA product code JQG covers "Radiometric, Fe59, Iron Binding Capacity", a Class I medical device regulated under 21 CFR 862.1415. Submissions are reviewed by the Clinical Chemistry panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JQG
- Device Class
- Class I
- Regulation Number
- 862.1415
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K811954 | immuno assay | COMBO-FER IRON DIAGNOSTIC | July 27, 1981 |
| K800710 | ria products | FERRITIRON KIT CAT. #RP-1100 | May 14, 1980 |
| K800868 | mallinckrodt critical care | FERRO-QUANT TM FE 59 TEST KIT | April 29, 1980 |
| K790133 | nuclear diagnostics | SPINSEP-FE59 | March 2, 1979 |
| K780412 | diagnostic corp. of america | TOTAL IRON BINDING CAPACITY | May 26, 1978 |