The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Systemate Creatinine (epos Application) #65413.
| Device ID | K905658 |
| 510k Number | K905658 |
| Device Name: | SYSTEMATE CREATININE (EPOS APPLICATION) #65413 |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Anna Bentley |
| Correspondent | Anna Bentley EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-18 |
| Decision Date | 1991-05-08 |