Cleared Traditional

K974606 - RANDOX MAGNESIUM

K974606 is an FDA 510(k) clearance for RANDOX MAGNESIUM, manufactured by Randox Laboratories, Ltd.. The device is a Class 1 Chemistry device with product code JGJ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K974606 · Randox Laboratories, Ltd. · Chemistry device
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Feb 1998
Decision
64d
Days
Class 1
Risk

K974606 is an FDA 510(k) clearance for the RANDOX MAGNESIUM. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on February 12, 1998 after a review of 64 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 Randox Laboratories, Ltd. devices

FDA 510(k) Submission Details - K974606

510(k) Number K974606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1997
Decision Date February 12, 1998
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

JGJ Device Classification - Class 1, General Controls

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 85
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K974606.
MG
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