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 |