The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for In Vitro Diag. For Uric Acid.
| Device ID | K770767 |
| 510k Number | K770767 |
| Device Name: | IN VITRO DIAG. FOR URIC ACID |
| Classification | Acid, Uric, Uricase (u.v.) |
| Applicant | SMITH KLINE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDO |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-04-28 |
| Decision Date | 1977-07-05 |