The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Uric Acid Reagent, Model Osr6x98.
| Device ID | K062862 |
| 510k Number | K062862 |
| Device Name: | OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Contact | Bev Harding |
| Correspondent | Bev Harding OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-25 |
| Decision Date | 2007-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590060152 | K062862 | 000 |
| 15099590020385 | K062862 | 000 |
| 15099590010942 | K062862 | 000 |
| 15099590000349 | K062862 | 000 |