Cleared Traditional

K882194 - GEMINII GAMMA COUNTER

K882194 is an FDA 510(k) clearance for GEMINII GAMMA COUNTER, manufactured by Laboratory Technologies, Inc.. The device is a Class 1 Toxicology device with product code JJE cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K882194 · Laboratory Technologies, Inc. · Toxicology device
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Aug 1988
Decision
71d
Days
Class 1
Risk

K882194 is an FDA 510(k) clearance for the GEMINII GAMMA COUNTER. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Laboratory Technologies, Inc. (Schaumburg, US). The FDA issued a Cleared decision on August 4, 1988 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2160 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K882194

510(k) Number K882194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1988
Decision Date August 04, 1988
Days to Decision 71 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 87d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

JJE Device Classification - Class 1, General Controls

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

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K882194 · GEMINII GAMMA COUNTER
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