Cleared Traditional

WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 (K012326) - FDA 510(k) Clearance

Class I Chemistry device.

K012326 · Wiener Laboratories Saic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
108d
Days
Class 1
Risk

K012326 is an FDA 510(k) clearance for the WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Wiener Laboratories Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on November 8, 2001 after a review of 108 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 Wiener Laboratories Saic devices

Submission Details

510(k) Number K012326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2001
Decision Date November 08, 2001
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
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 K012326.
Magnesium
K181748 · Abbott Laboratories · Sep 2018
Magnesium
K173294 · Abbott Laboratories · May 2018
Randox RX Daytona Plus Magnesium (MG)
K162200 · Randox Laboratories, Ltd. · Apr 2017
Atellica CH Magnesium (Mg)
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