Cleared Traditional

CORNING 4000 MULTI-WELL GAMMA COUNTER (K834508) - FDA 510(k) Clearance

Class I Toxicology device.

K834508 · Corning Medical & Scientific · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
86d
Days
Class 1
Risk

K834508 is an FDA 510(k) clearance for the CORNING 4000 MULTI-WELL GAMMA COUNTER. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on March 16, 1984 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Corning Medical & Scientific devices

Submission Details

510(k) Number K834508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1983
Decision Date March 16, 1984
Days to Decision 86 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 87d · This submission: 86d
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 K834508.
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