The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Au800 Clinical Chemistry Analyzer.
| Device ID | K920942 |
| 510k Number | K920942 |
| Device Name: | OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER |
| Classification | Analyzer, Chemistry, Centrifugal, For Clinical Use |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | JJG |
| CFR Regulation Number | 862.2140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-27 |
| Decision Date | 1992-06-10 |