Cleared Traditional

MAGNESIUM REAGENT SET

K855190 · Technostics Intl. · Chemistry
Feb 1986
Decision
54d
Days
Class 1
Risk

About This 510(k) Submission

K855190 is an FDA 510(k) clearance for the MAGNESIUM REAGENT SET, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Technostics Intl. (Washington, US). The FDA issued a Cleared decision on February 18, 1986, 54 days after receiving the submission on December 26, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K855190 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 1985
Decision Date February 18, 1986
Days to Decision 54 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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