The following data is part of a premarket notification filed by Kyoto Diagnostics, Inc. with the FDA for Urine Analyzer System.
| Device ID | K840996 |
| 510k Number | K840996 |
| Device Name: | URINE ANALYZER SYSTEM |
| Classification | Automated Urinalysis System |
| Applicant | KYOTO DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KQO |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-08 |
| Decision Date | 1984-05-01 |