Cleared Traditional

K943493 - DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER

K943493 is the FDA 510(k) clearance for DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER by Hamilton Co.. It is a Class 1 Chemistry device (product code JJE) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K943493 · Hamilton Co. · Chemistry device
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Jan 1995
Decision
195d
Days
Class 1
Risk

K943493 is an FDA 510(k) clearance for the DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Hamilton Co. (Snellville, US). The FDA issued a Cleared decision on January 30, 1995 after a review of 195 days - an extended review 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: 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 Hamilton Co. devices

Submission Details

510(k) Number K943493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1994
Decision Date January 30, 1995
Days to Decision 195 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
107d slower than avg
Panel avg: 88d · This submission: 195d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 143
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