The following data is part of a premarket notification filed by Olympus Diagnostica Gmbh with the FDA for Olympus Myoglobin Immunoturbidmetric Reagent.
| Device ID | K984145 |
| 510k Number | K984145 |
| Device Name: | OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| 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 | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-19 |
| Decision Date | 1998-12-23 |