The following data is part of a premarket notification filed by United Diagnostics, Inc. with the FDA for Stat-trak Liquid Electrolyte Control.
| Device ID | K831389 |
| 510k Number | K831389 |
| Device Name: | STAT-TRAK LIQUID ELECTROLYTE CONTROL |
| Classification | Electrolyte Controls (assayed And Unassayed) |
| Applicant | UNITED DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJR |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-29 |
| Decision Date | 1983-08-10 |