Cleared Traditional

STANBIO MAGNESIUM TEST SET, CAT. NO 0130 (K883170) - FDA 510(k) Clearance

Class I Chemistry device.

K883170 · Stanbio Laboratory · Chemistry device
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Feb 1989
Decision
195d
Days
Class 1
Risk

K883170 is an FDA 510(k) clearance for the STANBIO MAGNESIUM TEST SET, CAT. NO 0130. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Stanbio Laboratory (San Antonio, US). The FDA issued a Cleared decision on February 7, 1989 after a review of 195 days - an extended review 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: 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 Stanbio Laboratory devices

Submission Details

510(k) Number K883170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1988
Decision Date February 07, 1989
Days to Decision 195 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 88d · This submission: 195d
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 K883170.
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