Cleared Traditional

K862561 - TECHNICON RA-XT SYSTEM WITH ANALYTES

K862561 is an FDA 510(k) clearance for TECHNICON RA-XT SYSTEM WITH ANALYTES, manufactured by Technicon Instruments Corp.. The device is a Class 1 Chemistry device with product code JJC cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K862561 · Technicon Instruments Corp. · Chemistry device
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Oct 1986
Decision
109d
Days
Class 1
Risk

K862561 is an FDA 510(k) clearance for the TECHNICON RA-XT SYSTEM WITH ANALYTES. Classified as Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use (product code JJC), Class I - General Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on October 20, 1986 after a review of 109 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Technicon Instruments Corp. devices

FDA 510(k) Submission Details - K862561

510(k) Number K862561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1986
Decision Date October 20, 1986
Days to Decision 109 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
21d slower than avg
Panel avg: 88d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

JJC Device Classification - Class 1, General Controls

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 21
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