Submission Details
| 510(k) Number | K855190 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 26, 1985 |
| Decision Date | February 18, 1986 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
K855190 is an FDA 510(k) clearance for the MAGNESIUM REAGENT SET, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Technostics Intl. (Washington, US). The FDA issued a Cleared decision on February 18, 1986, 54 days after receiving the submission on December 26, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.
| 510(k) Number | K855190 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 26, 1985 |
| Decision Date | February 18, 1986 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JGJ — Photometric Method, Magnesium |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1495 |