The following data is part of a premarket notification filed by Immuno Assay Corp. with the FDA for Combo-fer Iron Diagnostic.
| Device ID | K811954 |
| 510k Number | K811954 |
| Device Name: | COMBO-FER IRON DIAGNOSTIC |
| Classification | Radiometric, Fe59, Iron Binding Capacity |
| Applicant | IMMUNO ASSAY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JQG |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-08 |
| Decision Date | 1981-07-27 |