Cleared Traditional

K935408 - UA PERFECT (FDA 510(k) Clearance)

Class I Chemistry device.

K935408 · Chimera Research & Chemical, Inc. · Chemistry device
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Jun 1994
Decision
216d
Days
Class 1
Risk

K935408 is an FDA 510(k) clearance for the UA PERFECT. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Chimera Research & Chemical, Inc. (Seminole, US). The FDA issued a Cleared decision on June 13, 1994 after a review of 216 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2900 - 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 Chimera Research & Chemical, Inc. devices

Submission Details

510(k) Number K935408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1993
Decision Date June 13, 1994
Days to Decision 216 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 88d · This submission: 216d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQO Automated Urinalysis System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2900
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.