Cleared Traditional

K922273 - ARRAY 360

K922273 is an FDA 510(k) clearance for ARRAY 360, 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 97-day FDA review.

K922273 · Beckman Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
97d
Days
Class 1
Risk

K922273 is an FDA 510(k) clearance for the ARRAY(R) 360. 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 19, 1992 after a review of 97 days - within the typical 510(k) review window.

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: 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K922273

510(k) Number K922273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1992
Decision Date August 19, 1992
Days to Decision 97 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
9d slower than avg
Panel avg: 88d · This submission: 97d
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
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