Cleared Traditional

K900087 - GENESYS 6000 GAMMA COUNTER

K900087 is the FDA 510(k) clearance for GENESYS 6000 GAMMA COUNTER by Laboratory Technologies, Inc.. It is a Class 1 Toxicology device (product code JJJ) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K900087 · Laboratory Technologies, Inc. · Toxicology device
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Jul 1990
Decision
195d
Days
Class 1
Risk

K900087 is an FDA 510(k) clearance for the GENESYS 6000 GAMMA COUNTER. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Laboratory Technologies, Inc. (Schaumburg, US). The FDA issued a Cleared decision on July 19, 1990 after a review of 195 days - an extended review cycle.

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

Submission Details

510(k) Number K900087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1990
Decision Date July 19, 1990
Days to Decision 195 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 87d · This submission: 195d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 26
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K900087.
ABBOTT VERTEX ANALYZER
K920559 · Abbott Laboratories · Mar 1992
1205 BETAPLATE LIQUID SCINTILLATION COUNTER
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TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER
K862206 · Micromedic Systems · Aug 1986
1208 BETACORD AND 1208 BETCORD M
K852434 · Lkb Instruments, Inc. · Aug 1985
MICROSTAT GAMMA COUNTER
K842902 · Micromedic Systems · Aug 1984
CORNING 4000 MULTI-WELL GAMMA COUNTER
K834508 · Corning Medical & Scientific · Mar 1984