The following data is part of a premarket notification filed by Icn Micromedic Systems with the FDA for Micromedic Ferritin Irma Kit.
| Device ID | K883746 |
| 510k Number | K883746 |
| Device Name: | MICROMEDIC FERRITIN IRMA KIT |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | ICN MICROMEDIC SYSTEMS 102 WITMER RD. Horsham, PA 19044 |
| Contact | Jeffrey Fleishman |
| Correspondent | Jeffrey Fleishman ICN MICROMEDIC SYSTEMS 102 WITMER RD. Horsham, PA 19044 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-01 |
| Decision Date | 1988-10-27 |