The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Hdl Cholesterol Reagent, Osr6195/osr6295 And Olympus Hdl Cholesterol Calibrator Odc0023.
| Device ID | K040692 |
| 510k Number | K040692 |
| Device Name: | OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023 |
| Classification | Calibrator, Secondary |
| 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 | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-17 |
| Decision Date | 2004-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590070502 | K040692 | 000 |
| 15099590020354 | K040692 | 000 |
| 15099590010911 | K040692 | 000 |