The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Ferro-quant Tm Fe 59 Test Kit.
| Device ID | K800868 |
| 510k Number | K800868 |
| Device Name: | FERRO-QUANT TM FE 59 TEST KIT |
| Classification | Radiometric, Fe59, Iron Binding Capacity |
| Applicant | MALLINCKRODT CRITICAL CARE 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 | 1980-04-17 |
| Decision Date | 1980-04-29 |