K840216 is an FDA 510(k) clearance for the SODIUM/POTASSIUM REAGENT SYS. This device is classified as a Flame Photometry, Sodium (Class II - Special Controls, product code JGT).
Submitted by Sclavo, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1984, 60 days after receiving the submission on January 19, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K840216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 1984 |
| Decision Date | March 19, 1984 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JGT — Flame Photometry, Sodium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1665 |