Cleared Traditional

K771369 - LIQ. SCINTILLATION SPECTROPHOTOMETEO

K771369 is an FDA 510(k) clearance for LIQ. SCINTILLATION SPECTROPHOTOMETEO, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Radiology device with product code JJJ cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K771369 · Beckman Instruments, Inc. · Radiology device
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Sep 1977
Decision
51d
Days
Class 1
Risk

K771369 is an FDA 510(k) clearance for the LIQ. SCINTILLATION SPECTROPHOTOMETEO. 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 September 14, 1977 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 862.2320 - the FDA radiology and imaging software oversight 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 - K771369

510(k) Number K771369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1977
Decision Date September 14, 1977
Days to Decision 51 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 107d · This submission: 51d
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 K771369.
GAMMA COUNTER
K780344 · Lkb Instruments, Inc. · Apr 1978
COUNTER, RADIOASSAY, AUTO., MICROMEDIC
K780383 · Micromedic Systems · Mar 1978
PRINTER
K772099 · Miles Laboratories, Inc. · Jan 1978
AUTO-LOGIC II SYSTEM
K771129 · Abbott Laboratories · Aug 1977
GAMMA GOUNTING SYS., AUTO, MODEL 1400
K771180 · G.D. Searle and Co. · Aug 1977
RADIOASSAY TUBES & RADIOASSAY TUBE CAPS
K770740 · G.D. Searle and Co. · Jun 1977