The following data is part of a premarket notification filed by Nordiclab Intl. with the FDA for Nordiclab Ferritin Irma Test.
| Device ID | K801989 |
| 510k Number | K801989 |
| Device Name: | NORDICLAB FERRITIN IRMA TEST |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | NORDICLAB INTL. 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 | 1980-08-19 |
| Decision Date | 1980-09-16 |