Cleared Traditional

K863069 - MAGNESIOMETER

K863069 is the FDA 510(k) clearance for MAGNESIOMETER by J. D. Assoc.. It is a Class 1 Chemistry device (product code JGJ) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K863069 · J. D. Assoc. · Chemistry device
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Dec 1986
Decision
141d
Days
Class 1
Risk

K863069 is an FDA 510(k) clearance for the MAGNESIOMETER. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on December 31, 1986 after a review of 141 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all J. D. Assoc. devices

Submission Details

510(k) Number K863069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1986
Decision Date December 31, 1986
Days to Decision 141 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
53d slower than avg
Panel avg: 88d · This submission: 141d
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 K863069.
MAGNESIUM REAGENT - CALMAGITE METHOD
K870370 · Trace Scientific , Ltd. · Aug 1987
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K872311 · Abbott Laboratories · Jul 1987
EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX
K870553 · Em Diagnostic Systems, Inc. · Mar 1987
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (MG)
K861386 · Eastman Kodak Company · Aug 1986
EMDS(TM) MAGNESIUM TESTPACKS, #67671/95
K863002 · Em Diagnostic Systems, Inc. · Aug 1986
MAGNESIUM PROCEDURE
K861668 · Data Medical Associates, Inc. · May 1986