Cleared Traditional

ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353

K983416 · Boehringer Mannheim Corp. · Chemistry

Oct 1998

Decision

22d

Days

Class 1

Risk

About This 510(k) Submission

K983416 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353, 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 review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number	K983416 FDA.gov
FDA Decision	Cleared 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