The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Rf Latex Calibrator, And Olympus Rf Latex Reagent With Model(s): Odc0028, And Osr61105..
| Device ID | K060201 |
| 510k Number | K060201 |
| Device Name: | OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. |
| Classification | System, Test, Rheumatoid Factor |
| 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 | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-26 |
| Decision Date | 2006-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590070571 | K060201 | 000 |
| 15099590010966 | K060201 | 000 |