The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Lyophilized Chemistry Calibrators Dr0070 And Dr0071.
| Device ID | K043460 |
| 510k Number | K043460 |
| Device Name: | OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 |
| Classification | Calibrator, Multi-analyte Mixture |
| 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 | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-15 |
| Decision Date | 2005-01-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590635602 | K043460 | 000 |
| 15099590635572 | K043460 | 000 |