Cleared Traditional

MAGNESIUM REAGENT

K905544 · Amresco, Inc. · Chemistry
Dec 1990
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K905544 is an FDA 510(k) clearance for the MAGNESIUM REAGENT, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on December 27, 1990, 16 days after receiving the submission on December 11, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K905544 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 1990
Decision Date December 27, 1990
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

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

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