
Boehringer Mannheim Corp.
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ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 is an FDA 510(k)-cleared medical device (K983416) manufactured by Boehringer Mannheim Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 20, 1998. Regulation: 8.