The following data is part of a premarket notification filed by Advocacy International, Ltd. with the FDA for Toyo Jozo Uric Acid Test.
| Device ID | K842103 |
| 510k Number | K842103 |
| Device Name: | TOYO JOZO URIC ACID TEST |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | ADVOCACY INTERNATIONAL, LTD. 1825 EYE ST. NW, STE 400 Washington, DC 20006 |
| Contact | Richard T Ney |
| Correspondent | Richard T Ney ADVOCACY INTERNATIONAL, LTD. 1825 EYE ST. NW, STE 400 Washington, DC 20006 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-25 |
| Decision Date | 1984-08-12 |