The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Lyophilized Calibrator, Models Dr0070 And Dr0071.
| Device ID | K032665 |
| 510k Number | K032665 |
| Device Name: | OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071 |
| Classification | Calibrator, Multi-analyte Mixture |
| 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 | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-28 |
| Decision Date | 2003-11-21 |