The following data is part of a premarket notification filed by Olympus Diagnostica Gmbh with the FDA for Olympus Calcium Arsenazo Iii Reagent.
| Device ID | K982035 |
| 510k Number | K982035 |
| Device Name: | OLYMPUS CALCIUM ARSENAZO III REAGENT |
| Classification | Azo Dye, Calcium |
| 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 | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-10 |
| Decision Date | 1998-06-24 |