The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Sodium And Potassium Standard.
| Device ID | K895717 |
| 510k Number | K895717 |
| Device Name: | SODIUM AND POTASSIUM STANDARD |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
| Contact | Annette T Wells |
| Correspondent | Annette T Wells DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-25 |
| Decision Date | 1990-01-11 |