Cleared Traditional

MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 (K063208) - FDA 510(k) Clearance

Class I Chemistry device.

K063208 · Diagnostic Chemicals , Ltd. · Chemistry device
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Jan 2007
Decision
88d
Days
Class 1
Risk

K063208 is an FDA 510(k) clearance for the MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on January 19, 2007 after a review of 88 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 Diagnostic Chemicals , Ltd. devices

Submission Details

510(k) Number K063208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2006
Decision Date January 19, 2007
Days to Decision 88 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 88d · This submission: 88d
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 89
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K063208.
Magnesium
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K162200 · Randox Laboratories, Ltd. · Apr 2017
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K162399 · Siemens Healthcare Diagnostics, Inc. · Jan 2017
MG
K981791 · Abbott Laboratories · Oct 1998
ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353
K983416 · Boehringer Mannheim Corp. · Oct 1998