The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Au 5000 Flame Photometer Module.
| Device ID | K862148 |
| 510k Number | K862148 |
| Device Name: | OLYMPUS AU 5000 FLAME PHOTOMETER MODULE |
| Classification | Flame Emission Photometer For Clinical Use |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Michael C Krenz |
| Correspondent | Michael C Krenz OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | JJO |
| CFR Regulation Number | 862.2540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-04 |
| Decision Date | 1986-09-29 |