Cleared Traditional

K915106 - DIMENSION AR CLINICAL CHEMISTRY SYSTEM

K915106 is an FDA 510(k) clearance for DIMENSION AR CLINICAL CHEMISTRY SYSTEM, manufactured by Dupont Medical Products. The device is a Class 1 Chemistry device with product code JJE cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K915106 · Dupont Medical Products · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
76d
Days
Class 1
Risk

K915106 is an FDA 510(k) clearance for the DIMENSION AR CLINICAL CHEMISTRY SYSTEM. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Dupont Medical Products (Wilmington, US). The FDA issued a Cleared decision on January 28, 1992 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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 Dupont Medical Products devices

FDA 510(k) Submission Details - K915106

510(k) Number K915106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1991
Decision Date January 28, 1992
Days to Decision 76 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
12d faster than avg
Panel avg: 88d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

JJE Device Classification - Class 1, General Controls

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 144
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