Cleared Traditional

K841847 - LITHIUM REAGENT

K841847 is an FDA 510(k) clearance for LITHIUM REAGENT, manufactured by Reagent Laboratory, Inc.. The device is a Class 1 Toxicology device with product code JJO cleared through the Traditional 510(k) pathway after a 121-day FDA review.

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

FDA 510(k) Submission Details - K841847

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 87d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

JJO Device Classification - Class 1, General Controls

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.

Regulatory Peers - JJO Flame Emission Photometer For Clinical Use

All 15
Devices cleared under the same product code (JJO) and FDA review panel - the closest regulatory comparables to K841847.
OLYMPUS AU 5000 FLAME PHOTOMETER MODULE
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SHABAN #9852 CHIMNEY-#9854 SCREEN &
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