K983416 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353. This device is classified as a Photometric Method, Magnesium (Class I - General Controls, product code JGJ).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 21, 1998, 22 days after receiving the submission on September 29, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1495.
| 510(k) Number | K983416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 1998 |
| Decision Date | October 21, 1998 |
| Days to Decision | 22 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 |