The following data is part of a premarket notification filed by American Dade with the FDA for Paramax Electrolyte Calibrator.
| Device ID | K863489 |
| 510k Number | K863489 |
| Device Name: | PARAMAX ELECTROLYTE CALIBRATOR |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | Krista L Underwood |
| Correspondent | Krista L Underwood AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-09 |
| Decision Date | 1986-09-29 |