Cleared Traditional

K802091 - AMERICAN MONITOR MAGNESIUM #'S 1036&4021

K802091 is the FDA 510(k) clearance for AMERICAN MONITOR MAGNESIUM #'S 1036&4021 by American Monitor Corp.. It is a Class 1 Chemistry device (product code JGJ) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K802091 · American Monitor Corp. · Chemistry device
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Oct 1980
Decision
38d
Days
Class 1
Risk

K802091 is an FDA 510(k) clearance for the AMERICAN MONITOR MAGNESIUM #'S 1036&4021. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by American Monitor Corp. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1495 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Monitor Corp. devices

Submission Details

510(k) Number K802091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1980
Decision Date October 10, 1980
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JGJ Photometric Method, Magnesium
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1495
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JGJ Photometric Method, Magnesium

All 65
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K802091.
MAGNESIUM B TEST
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MAGNESIUM TEST KIT
K803088 · Mallinckrodt Critical Care · Jan 1981
ELVI MAGNESIUM
K792399 · Volu Sol Medical Industries · Dec 1979
MULTISTAT III MAGNESIUM TEST
K771469 · Instrumentation Laboratory CO · Sep 1977