K831300 is an FDA 510(k) clearance for the MSI-NAK-50 TEST KIT. This device is classified as a Flame Photometry, Potassium (Class II - Special Controls, product code JGM).
Submitted by Medical Specialties, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983, 88 days after receiving the submission on April 21, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1600.
| 510(k) Number | K831300 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 1983 |
| Decision Date | July 18, 1983 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JGM — Flame Photometry, Potassium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1600 |