The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco Ferritin-quant Diag. Test Kit.
| Device ID | K811880 |
| 510k Number | K811880 |
| Device Name: | LEECO FERRITIN-QUANT DIAG. TEST KIT |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | LEECO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-01 |
| Decision Date | 1981-07-16 |