Cleared Traditional

ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED (K944202) - FDA 510(k) Clearance

Class I Chemistry device.

K944202 · Abbott Laboratories · Chemistry device
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Nov 1994
Decision
95d
Days
Class 1
Risk

K944202 is an FDA 510(k) clearance for the ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 14, 1994 after a review of 95 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 Abbott Laboratories devices

Submission Details

510(k) Number K944202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1994
Decision Date November 14, 1994
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 88d · This submission: 95d
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 36
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K944202.
MG
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URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS
K926144 · Heraeus Kulzer, Inc. · Jan 1993
OLYMPUS MAGNESIUM REAGENT
K924658 · Olympus Corp. · Oct 1992