Cleared Traditional

BECKMAN LIQUID-STAT MAGNESIUM REAGENT & STANDARD (K883967) - FDA 510(k) Clearance

Class I Chemistry device.

K883967 · Beckman Instruments, Inc. · Chemistry device
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Jan 1989
Decision
129d
Days
Class 1
Risk

K883967 is an FDA 510(k) clearance for the BECKMAN LIQUID-STAT MAGNESIUM REAGENT & STANDARD. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on January 27, 1989 after a review of 129 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K883967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1988
Decision Date January 27, 1989
Days to Decision 129 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
41d slower than avg
Panel avg: 88d · This submission: 129d
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 K883967.
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K885022 · Em Diagnostic Systems, Inc. · Jan 1989
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K883972 · Sigma Chemical Co. · Nov 1988