The following data is part of a premarket notification filed by Diagnostic Systems with the FDA for Olympus Urine Ph.
| Device ID | K905146 |
| 510k Number | K905146 |
| Device Name: | OLYMPUS URINE PH |
| Classification | Ph Meter |
| Applicant | DIAGNOSTIC SYSTEMS 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Anna Bentley |
| Correspondent | Anna Bentley DIAGNOSTIC SYSTEMS 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | JQY |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-15 |
| Decision Date | 1991-02-04 |