Cleared Traditional

NUCLEAR ENTERPRISES 1600/GAMMA COUNTER (K801264) - FDA 510(k) Clearance

Class I Toxicology device.

K801264 · Nuclear Ent. , Ltd. · Toxicology device
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Jun 1980
Decision
29d
Days
Class 1
Risk

K801264 is an FDA 510(k) clearance for the NUCLEAR ENTERPRISES 1600/GAMMA COUNTER. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Nuclear Ent. , Ltd. (Mchenry, US). The FDA issued a Cleared decision on June 26, 1980 after a review of 29 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 Nuclear Ent. , Ltd. devices

Submission Details

510(k) Number K801264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1980
Decision Date June 26, 1980
Days to Decision 29 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 87d · This submission: 29d
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 K801264.
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