The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Ferritin Irma.
| Device ID | K841925 |
| 510k Number | K841925 |
| Device Name: | DSL FERRITIN IRMA |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, 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 | 1984-05-10 |
| Decision Date | 1984-05-25 |