The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Ferritin Reagent.
| Device ID | K030124 |
| 510k Number | K030124 |
| Device Name: | OLYMPUS FERRITIN REAGENT |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Contact | Michael Campbell |
| Correspondent | Michael Campbell OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-14 |
| Decision Date | 2003-02-06 |