Cleared Traditional

K833023 - TECHNICON RA-1000 SYSTEM

K833023 is the FDA 510(k) clearance for TECHNICON RA-1000 SYSTEM by Technicon Instruments Corp.. It is a Class 1 Chemistry device (product code JJC) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K833023 · Technicon Instruments Corp. · Chemistry device
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Nov 1983
Decision
58d
Days
Class 1
Risk

K833023 is an FDA 510(k) clearance for the TECHNICON RA-1000 SYSTEM. Classified as Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use (product code JJC), Class I - General Controls.

Submitted by Technicon Instruments Corp. (Walker, US). The FDA issued a Cleared decision on November 3, 1983 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2150 - 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K833023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1983
Decision Date November 03, 1983
Days to Decision 58 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
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJC Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2150
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 - JJC Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use

All 18
Devices cleared under the same product code (JJC) and FDA review panel - the closest regulatory comparables to K833023.
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TECHNICON RA-500 SYSTEM
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LANCER ANALYZER CUPS
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TECHNICON SMAC II SYSTEM & ACCESSORIES
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K792285 · Technicon Instruments Corp. · Dec 1979