The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Uric Acid Reagent.
| Device ID | K955752 |
| 510k Number | K955752 |
| Device Name: | OLYMPUS URIC ACID REAGENT |
| Classification | Acid, Uric, Uricase (u.v.) |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | CDO |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-19 |
| Decision Date | 1996-01-31 |