Submission Details
| 510(k) Number | K905544 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 11, 1990 |
| Decision Date | December 27, 1990 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
K905544 is an FDA 510(k) clearance for the MAGNESIUM REAGENT, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on December 27, 1990, 16 days after receiving the submission on December 11, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.
| 510(k) Number | K905544 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 11, 1990 |
| Decision Date | December 27, 1990 |
| Days to Decision | 16 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 |