Cleared Traditional

IMMPULSE SYSTEM (K834070) - FDA 510(k) Clearance

Class I Immunology device.

K834070 · Paragon Diagnostics, Inc. · Immunology device
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Mar 1984
Decision
119d
Days
Class 1
Risk

K834070 is an FDA 510(k) clearance for the IMMPULSE SYSTEM. Classified as Fluorometer (product code JZT), Class I - General Controls.

Submitted by Paragon Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.4520 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Paragon Diagnostics, Inc. devices

Submission Details

510(k) Number K834070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1983
Decision Date March 23, 1984
Days to Decision 119 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 104d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JZT Fluorometer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.4520
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.