Cleared Traditional

GENESYS 6000 GAMMA COUNTER (K900087) - FDA 510(k) Clearance

Class I Toxicology device.

K900087 · Laboratory Technologies, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 62
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
LS 5800 SERIES LIQUID SCINTILLATION
K813472 · Beckman Instruments, Inc. · Dec 1981
LIQUID SCINTILLATION SPECTROPHOTOMETER
K810345 · Beckman Instruments, Inc. · Feb 1981
NUCLEAR SAMPLE READER
K790905 · Abbott Laboratories · Jun 1979
LIQ. SCINTILLATION SPECTROPHOTOMETEO
K771369 · Beckman Instruments, Inc. · Sep 1977
AUTO-LOGIC II SYSTEM
K771129 · Abbott Laboratories · Aug 1977