510(k) K983416

ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 by Boehringer Mannheim Corp. — Product Code JGJ

K983416 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353". The FDA issued a decision of Substantially Equivalent on October 21, 1998. The device falls under product code JGJ (Photometric Method, Magnesium), a Class I device regulated under 21 CFR 862.1495. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.