The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Systemate Plus Calibrator.
| Device ID | K925101 |
| 510k Number | K925101 |
| Device Name: | SYSTEMATE PLUS CALIBRATOR |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Anna G Bentley |
| Correspondent | Anna G Bentley EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-08 |
| Decision Date | 1993-02-23 |