Cleared Traditional

K944407 - OLYMPUS MAGNESIUM REAGENT

K944407 is an FDA 510(k) clearance for OLYMPUS MAGNESIUM REAGENT, manufactured by Olympus America, Inc.. The device is a Class 1 Chemistry device with product code JGJ cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K944407 · Olympus America, Inc. · Chemistry device
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Dec 1994
Decision
110d
Days
Class 1
Risk

K944407 is an FDA 510(k) clearance for the OLYMPUS MAGNESIUM REAGENT. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Olympus America, Inc. (Lake Success, US). The FDA issued a Cleared decision on December 27, 1994 after a review of 110 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 Olympus America, Inc. devices

FDA 510(k) Submission Details - K944407

510(k) Number K944407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1994
Decision Date December 27, 1994
Days to Decision 110 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 88d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

JGJ Device Classification - Class 1, General Controls

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

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