Cleared Traditional

K952501 - TOX PERFECT B TUBES AND REAGENTS (FDA 510(k) Clearance)

Class I Chemistry device.

K952501 · Chimera Research & Chemical, Inc. · Chemistry device
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Aug 1995
Decision
86d
Days
Class 1
Risk

K952501 is an FDA 510(k) clearance for the TOX PERFECT B TUBES AND REAGENTS. Classified as Columns, Liquid Chromatography (product code DPM), Class I - General Controls.

Submitted by Chimera Research & Chemical, Inc. (Seminole, US). The FDA issued a Cleared decision on August 24, 1995 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2260 - 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 Chimera Research & Chemical, Inc. devices

Submission Details

510(k) Number K952501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1995
Decision Date August 24, 1995
Days to Decision 86 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
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DPM Columns, Liquid Chromatography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2260
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.