Cleared Traditional

K841847 - LITHIUM REAGENT (FDA 510(k) Clearance)

Class I Toxicology device.

K841847 · Reagent Laboratory, Inc. · Toxicology device
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Aug 1984
Decision
121d
Days
Class 1
Risk

K841847 is an FDA 510(k) clearance for the LITHIUM REAGENT. Classified as Flame Emission Photometer For Clinical Use (product code JJO), Class I - General Controls.

Submitted by Reagent Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 17, 1984 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2540 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Reagent Laboratory, Inc. devices

Submission Details

510(k) Number K841847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1984
Decision Date August 17, 1984
Days to Decision 121 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 87d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJO Flame Emission Photometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2540
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.