The following data is part of a premarket notification filed by Olympus Diagnostica Gmbh with the FDA for Olympus Serum Protein Multicalibrator,.
| Device ID | K981854 |
| 510k Number | K981854 |
| Device Name: | OLYMPUS SERUM PROTEIN MULTICALIBRATOR, |
| Classification | Calibrator, Secondary |
| Applicant | OLYMPUS DIAGNOSTICA GMBH TWO CORPORATE CENTER DR. Melville, NY 11747 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS DIAGNOSTICA GMBH TWO CORPORATE CENTER DR. Melville, NY 11747 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-26 |
| Decision Date | 1998-08-18 |