The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Unsaturated Iron Binding Capcity Reagent, Osr6124/0sr6524.
| Device ID | K041793 |
| 510k Number | K041793 |
| Device Name: | OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| Applicant | OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Contact | Bev Harding |
| Correspondent | Bev Harding OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Product Code | JMO |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-02 |
| Decision Date | 2004-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590011925 | K041793 | 000 |