K832552 is an FDA 510(k) clearance for the SODIUM TEST KIT. This device is classified as a Uranyl Acetate/zinc Acetate, Sodium (Class II - Special Controls, product code CEI).
Submitted by Mallinckrodt Critical Care (Mchenry, US). The FDA issued a Cleared decision on September 20, 1983, 50 days after receiving the submission on August 1, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K832552 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1983 |
| Decision Date | September 20, 1983 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CEI — Uranyl Acetate/zinc Acetate, Sodium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1665 |