Cleared Traditional

K801263 - NUCLEAR ENTERPRISES 1612 MULTI-WELL

K801263 is the FDA 510(k) clearance for NUCLEAR ENTERPRISES 1612 MULTI-WELL by Nuclear Ent. , Ltd.. It is a Class 1 Toxicology device (product code JJJ) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K801263 · Nuclear Ent. , Ltd. · Toxicology device
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Jun 1980
Decision
23d
Days
Class 1
Risk

K801263 is an FDA 510(k) clearance for the NUCLEAR ENTERPRISES 1612 MULTI-WELL. 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 20, 1980 after a review of 23 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 K801263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1980
Decision Date June 20, 1980
Days to Decision 23 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 87d · This submission: 23d
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 27
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K801263.
LS 5800 SERIES LIQUID SCINTILLATION
K813472 · Beckman Instruments, Inc. · Dec 1981
LIQUID SCINTILLATION SPECTROPHOTOMETER
K810345 · Beckman Instruments, Inc. · Feb 1981
PACE-4-AUTOMATIC RIA GAMMA-COUTER
K802578 · Philips Medical Systems (Cleveland), Inc. · Dec 1980
NUCLEAR SAMPLE READER
K790905 · Abbott Laboratories · Jun 1979
SCINTILLATION, LIQUID, RACKBETA
K780341 · Lkb Instruments, Inc. · May 1978
GAMMA COUNTER
K780344 · Lkb Instruments, Inc. · Apr 1978