K181748 is an FDA 510(k) clearance for the Magnesium. This device is classified as a Photometric Method, Magnesium (Class I - General Controls, product code JGJ).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on September 12, 2018, 72 days after receiving the submission on July 2, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1495.
| 510(k) Number | K181748 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2018 |
| Decision Date | September 12, 2018 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JGJ — Photometric Method, Magnesium |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1495 |