The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Ferritin Immunoturbidimetric Reagent.
| Device ID | K963170 |
| 510k Number | K963170 |
| Device Name: | OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-14 |
| Decision Date | 1996-12-02 |