Cleared Traditional

K862206 - TAURUS (TM) AUTOMATIC LIQUID SCINTILLAT...

K862206 is the FDA 510(k) clearance for TAURUS (TM) AUTOMATIC LIQUID SCINTILLAT... by Micromedic Systems. It is a Class 1 Chemistry device (product code JJJ) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K862206 · Micromedic Systems · Chemistry device
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Aug 1986
Decision
55d
Days
Class 1
Risk

K862206 is an FDA 510(k) clearance for the TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Micromedic Systems (Horsham, US). The FDA issued a Cleared decision on August 4, 1986 after a review of 55 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.

View all Micromedic Systems devices

Submission Details

510(k) Number K862206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1986
Decision Date August 04, 1986
Days to Decision 55 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
33d faster than avg
Panel avg: 88d · This submission: 55d
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 K862206.
ABBOTT VERTEX ANALYZER
K920559 · Abbott Laboratories · Mar 1992
1205 BETAPLATE LIQUID SCINTILLATION COUNTER
K874094 · Lkb Instruments, Inc. · Nov 1987
1208 BETACORD AND 1208 BETCORD M
K852434 · Lkb Instruments, Inc. · Aug 1985
MICROSTAT GAMMA COUNTER
K842902 · Micromedic Systems · Aug 1984
CORNING 4000 MULTI-WELL GAMMA COUNTER
K834508 · Corning Medical & Scientific · Mar 1984
RIA STAT 16
K821494 · E. R. Squibb & Sons, Inc. · Jun 1982