The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Au5400 Clinical Chemistry Analyzer.
| Device ID | K011720 |
| 510k Number | K011720 |
| Device Name: | OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER |
| Classification | Bromcresol Green Dye-binding, Albumin |
| 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 | CIX |
| Subsequent Product Code | CDO |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CDT |
| Subsequent Product Code | CEK |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CFJ |
| Subsequent Product Code | CFQ |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CGS |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CHH |
| Subsequent Product Code | CHS |
| Subsequent Product Code | CIC |
| Subsequent Product Code | CIG |
| Subsequent Product Code | CIT |
| Subsequent Product Code | CJE |
| Subsequent Product Code | CKA |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-04 |
| Decision Date | 2001-06-25 |