The following data is part of a premarket notification filed by Kyoto Diagnostics, Inc. with the FDA for Kyotest Ugk.
| Device ID | K840829 |
| 510k Number | K840829 |
| Device Name: | KYOTEST UGK |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | KYOTO DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JIL |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-24 |
| Decision Date | 1984-04-19 |