Cleared Traditional

K834070 - IMMPULSE SYSTEM

K834070 is an FDA 510(k) clearance for IMMPULSE SYSTEM, manufactured by Paragon Diagnostics, Inc.. The device is a Class 1 Immunology device with product code JZT cleared through the Traditional 510(k) pathway after a 119-day FDA review.

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

FDA 510(k) Submission Details - K834070

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
14d slower than avg
Panel avg: 105d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

JZT Device Classification - Class 1, General Controls

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.

Regulatory Peers - JZT Fluorometer

All 8
Devices cleared under the same product code (JZT) and FDA review panel - the closest regulatory comparables to K834070.
PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM
K862674 · Hybritech, Inc. · Aug 1986
FLUOROSKAN
K842049 · Flow Laboratories, Inc. · Dec 1984
FIAX 100 FLUOROMETER
K843356 · Intl. Diagnostic Technology · Sep 1984
FLUROMETER, DADE
K782150 · Dade, Baxter Travenol Diagnostics, Inc. · Feb 1979
VIEWER, FLUOROMETIC, MODEL 721
K770662 · Corning Medical & Scientific · Apr 1977