Cleared Traditional

K851689 - GENESYS GAMMA COUNTER

K851689 is an FDA 510(k) clearance for GENESYS GAMMA COUNTER, manufactured by Laboratory Technologies, Inc.. The device is a Class 1 Toxicology device with product code JJJ cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K851689 · Laboratory Technologies, Inc. · Toxicology device
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Aug 1985
Decision
103d
Days
Class 1
Risk

K851689 is an FDA 510(k) clearance for the GENESYS GAMMA COUNTER. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Laboratory Technologies, Inc. (Elburn, US). The FDA issued a Cleared decision on August 7, 1985 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2320 - 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 Laboratory Technologies, Inc. devices

FDA 510(k) Submission Details - K851689

510(k) Number K851689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1985
Decision Date August 07, 1985
Days to Decision 103 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 slower than avg
Panel avg: 87d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

JJJ Device Classification - Class 1, General Controls

Product Code JJJ Counter (beta, Gamma) For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2320
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 - JJJ Counter (beta, Gamma) For Clinical Use

All 33
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K851689.
1205 BETAPLATE LIQUID SCINTILLATION COUNTER
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DENTOCULT CULTURE-PADDLE
K851164 · Orion Corp. · Oct 1985
1208 BETACORD AND 1208 BETCORD M
K852434 · Lkb Instruments, Inc. · Aug 1985
MICROSTAT GAMMA COUNTER
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CORNING 4000 MULTI-WELL GAMMA COUNTER
K834508 · Corning Medical & Scientific · Mar 1984