K981192 is an FDA 510(k) clearance for the MG. 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 May 1, 1998, 29 days after receiving the submission on April 2, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1495.
| 510(k) Number | K981192 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 1998 |
| Decision Date | May 01, 1998 |
| Days to Decision | 29 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 |