The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Uric Acid Kit, Codes 4825400 And 4825050.
| Device ID | K890319 |
| 510k Number | K890319 |
| Device Name: | URIC ACID KIT, CODES 4825400 AND 4825050 |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Contact | Dianne Eich |
| Correspondent | Dianne Eich AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-23 |
| Decision Date | 1989-04-12 |