The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Autokit Uric Acid.
| Device ID | K880731 |
| 510k Number | K880731 |
| Device Name: | WAKO AUTOKIT URIC ACID |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | WAKO CHEMICALS, USA, INC. 12300 FORD RD. SUITE 130 Dallas, TX 75234 |
| Contact | Toshihiko Oda |
| Correspondent | Toshihiko Oda WAKO CHEMICALS, USA, INC. 12300 FORD RD. SUITE 130 Dallas, TX 75234 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-24 |
| Decision Date | 1988-03-24 |