Cleared Traditional

URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS (K926144) - FDA 510(k) Clearance

Class I Chemistry device.

K926144 · Heraeus Kulzer, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
51d
Days
Class 1
Risk

K926144 is an FDA 510(k) clearance for the URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Heraeus Kulzer, Inc. (Tarrytown, US). The FDA issued a Cleared decision on January 27, 1993 after a review of 51 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K926144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1992
Decision Date January 27, 1993
Days to Decision 51 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
37d faster than avg
Panel avg: 88d · This submission: 51d
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 34
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K926144.
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