Cleared Traditional

K962294 - IMMAGE IMMUNOCHEMISTRY SYSTEM

K962294 is an FDA 510(k) clearance for IMMAGE IMMUNOCHEMISTRY SYSTEM, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Chemistry device with product code JQX cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K962294 · Beckman Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
68d
Days
Class 1
Risk

K962294 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM. Classified as Nephelometer, For Clinical Use (product code JQX), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on August 21, 1996 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2700 - 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K962294

510(k) Number K962294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1996
Decision Date August 21, 1996
Days to Decision 68 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 88d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

JQX Device Classification - Class 1, General Controls

Product Code JQX Nephelometer, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2700
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 - JQX Nephelometer, For Clinical Use

All 10
Devices cleared under the same product code (JQX) and FDA review panel - the closest regulatory comparables to K962294.
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