Cleared Traditional

NUCLEAR SAMPLE READER (K790905) - FDA 510(k) Clearance

Class I Toxicology device.

K790905 · Abbott Laboratories · Toxicology device
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Jun 1979
Decision
35d
Days
Class 1
Risk

K790905 is an FDA 510(k) clearance for the NUCLEAR SAMPLE READER. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 15, 1979 after a review of 35 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 Abbott Laboratories devices

Submission Details

510(k) Number K790905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1979
Decision Date June 15, 1979
Days to Decision 35 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 87d · This submission: 35d
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 12
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K790905.
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
PRINTER
K772099 · Miles Laboratories, Inc. · Jan 1978
LIQ. SCINTILLATION SPECTROPHOTOMETEO
K771369 · Beckman Instruments, Inc. · Sep 1977
AUTO-LOGIC II SYSTEM
K771129 · Abbott Laboratories · Aug 1977