The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Au2700 Clinical Chemistry Analyzer.
| Device ID | K002982 |
| 510k Number | K002982 |
| Device Name: | OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| 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 | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-25 |
| Decision Date | 2000-10-25 |