Cleared Traditional

K883170 - STANBIO MAGNESIUM TEST SET

K883170 is the FDA 510(k) clearance for STANBIO MAGNESIUM TEST SET by Stanbio Laboratory. It is a Class 1 Chemistry device (product code JGJ) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

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.

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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
Combination Product No
PCCP Authorized No
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 58
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K883170.
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K885022 · Em Diagnostic Systems, Inc. · Jan 1989