K964915 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 Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on March 26, 1997, 107 days after receiving the submission on December 9, 1996.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1495.
| 510(k) Number | K964915 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 1996 |
| Decision Date | March 26, 1997 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JGJ — Photometric Method, Magnesium |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1495 |