Cleared Traditional

TRACE MAGNESIUM - ARSENAZO REAGENT

K920603 · Trace America, Inc. · Chemistry
Mar 1992
Decision
39d
Days
Class 1
Risk

About This 510(k) Submission

K920603 is an FDA 510(k) clearance for the TRACE MAGNESIUM - ARSENAZO REAGENT, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on March 11, 1992, 39 days after receiving the submission on February 1, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K920603 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 1992
Decision Date March 11, 1992
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JGJ — Photometric Method, Magnesium
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1495

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