K111915 is an FDA 510(k) clearance for the MAGNESIUM ASSAY. This device is classified as a Photometric Method, Magnesium (Class I - General Controls, product code JGJ).
Submitted by Sekisui Diagnostics P.E.I., Inc. (Prince Edward Island, CA). The FDA issued a Cleared decision on December 2, 2011, 149 days after receiving the submission on July 6, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1495.
| 510(k) Number | K111915 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2011 |
| Decision Date | December 02, 2011 |
| Days to Decision | 149 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 |