Cleared Traditional

MAGNESIUM REAGENT SET (K882256) - FDA 510(k) Clearance

Class I Chemistry device.

K882256 · Tech-Neal Scientific, Inc. · Chemistry device
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Aug 1988
Decision
69d
Days
Class 1
Risk

K882256 is an FDA 510(k) clearance for the MAGNESIUM REAGENT SET. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Tech-Neal Scientific, Inc. (Chicago, US). The FDA issued a Cleared decision on August 8, 1988 after a review of 69 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 Tech-Neal Scientific, Inc. devices

Submission Details

510(k) Number K882256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1988
Decision Date August 08, 1988
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 88d · This submission: 69d
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 24
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K882256.
BECKMAN LIQUID-STAT MAGNESIUM REAGENT & STANDARD
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MAGNESIUM TEST ITEM NUMBER: SR1019
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MAGNESIUM REAGENT (MAGON SULFONATE)
K883972 · Sigma Chemical Co. · Nov 1988
KODAK EKTACHEM DT SLIDES (MG)
K874576 · Eastman Kodak Company · Jan 1988
PARAMAX MAGNESIUM REAGENT
K873530 · Baxter Healthcare Corp · Dec 1987
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT
K872311 · Abbott Laboratories · Jul 1987