Cleared Traditional

K943493 - DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER

K943493 is an FDA 510(k) clearance for DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER, manufactured by Hamilton Co.. The device is a Class 1 Chemistry device with 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.

FDA 510(k) Submission Details - K943493

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 89d · This submission: 195d
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

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K943493 · DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER
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