Cleared Traditional

K953393 - TOX PERFECT A TUBE (FDA 510(k) Clearance)

Class I Chemistry device.

K953393 · Chimera Research & Chemical, Inc. · Chemistry device
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Oct 1995
Decision
84d
Days
Class 1
Risk

K953393 is an FDA 510(k) clearance for the TOX PERFECT A TUBE. Classified as Digoxin Control Serum, Ria (product code DMP), Class I - General Controls.

Submitted by Chimera Research & Chemical, Inc. (Seminole, US). The FDA issued a Cleared decision on October 6, 1995 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - 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 K953393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1995
Decision Date October 06, 1995
Days to Decision 84 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
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DMP Digoxin Control Serum, Ria
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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.