Cleared Traditional

K813472 - LS 5800 SERIES LIQUID SCINTILLATION

K813472 is an FDA 510(k) clearance for LS 5800 SERIES LIQUID SCINTILLATION, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Toxicology device with product code JJJ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K813472 · Beckman Instruments, Inc. · Toxicology device
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Dec 1981
Decision
15d
Days
Class 1
Risk

K813472 is an FDA 510(k) clearance for the LS 5800 SERIES LIQUID SCINTILLATION. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 29, 1981 after a review of 15 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K813472

510(k) Number K813472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1981
Decision Date December 29, 1981
Days to Decision 15 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
72d faster than avg
Panel avg: 87d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

JJJ Device Classification - Class 1, General Controls

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 K813472.
CORNING 4000 MULTI-WELL GAMMA COUNTER
K834508 · Corning Medical & Scientific · Mar 1984
RIA STAT 16
K821494 · E. R. Squibb & Sons, Inc. · Jun 1982
MICROMEDIC SYSTEMS ISOFLEX
K820376 · Micromedic Systems · Mar 1982
LIQUID SCINTILLATION SPECTROPHOTOMETER
K810345 · Beckman Instruments, Inc. · Feb 1981
PACE-4-AUTOMATIC RIA GAMMA-COUTER
K802578 · Philips Medical Systems (Cleveland), Inc. · Dec 1980
HYDRAGAMMA 16
K800601 · Innotron of Oregon, Inc. · Apr 1980