K831389 is an FDA 510(k) clearance for the STAT-TRAK LIQUID ELECTROLYTE CONTROL. This device is classified as a Electrolyte Controls (assayed And Unassayed) (Class I - General Controls, product code JJR).
Submitted by United Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1983, 103 days after receiving the submission on April 29, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K831389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1983 |
| Decision Date | August 10, 1983 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJR — Electrolyte Controls (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |