Cleared Traditional

K874094 - 1205 BETAPLATE LIQUID SCINTILLATION COUNTER

K874094 is an FDA 510(k) clearance for 1205 BETAPLATE LIQUID SCINTILLATION COUNTER, manufactured by Lkb Instruments, Inc.. The device is a Class 1 Chemistry device with product code JJJ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K874094 · Lkb Instruments, Inc. · Chemistry device
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Nov 1987
Decision
35d
Days
Class 1
Risk

K874094 is an FDA 510(k) clearance for the 1205 BETAPLATE LIQUID SCINTILLATION COUNTER. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Lkb Instruments, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on November 4, 1987 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2320 - the FDA in vitro diagnostics and chemistry 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.

FDA 510(k) Submission Details - K874094

510(k) Number K874094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1987
Decision Date November 04, 1987
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 89d · This submission: 35d
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 62
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K874094.
SOURCERER
K894902 · Oakfield Instruments, Ltd. · Oct 1989
SOURCERER
K884091 · John Caunt Scientific , Ltd. · Feb 1989
SAMPLE IDENTIFICATION STATION MODEL 38010
K884269 · Icn Micromedic Systems · Jan 1989
ISO-DATA 100 SERIES GAMMA COUNTER
K872429 · Iso-Data, Inc. · Aug 1987
ISO-DATA 500 SERIES GAMMA COUNTER
K872430 · Iso-Data, Inc. · Aug 1987
BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS
K870115 · Berthold Analytical Instruments, Inc. · Mar 1987
K874094 · 1205 BETAPLATE LIQUID SCINTILLATION COUNTER
Download PDF Lkb Instruments, Inc.