Cleared Traditional

K961896 - MICROLAB 4000

K961896 is the FDA 510(k) clearance for MICROLAB 4000 by Hamilton Co.. It is a Class 1 Chemistry device (product code JQW) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K961896 · Hamilton Co. · Chemistry device
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Aug 1996
Decision
92d
Days
Class 1
Risk

K961896 is an FDA 510(k) clearance for the MICROLAB 4000, MICROLAB 4200. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Hamilton Co. (Reno, US). The FDA issued a Cleared decision on August 16, 1996 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - 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 K961896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1996
Decision Date August 16, 1996
Days to Decision 92 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 slower than avg
Panel avg: 88d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
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 - JQW Station, Pipetting And Diluting, For Clinical Use

All 64
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