Cleared Traditional

K953345 - GENESIS

K953345 is an FDA 510(k) clearance for GENESIS, manufactured by Tecan U.S., Inc.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K953345 · Tecan U.S., Inc. · Chemistry device
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Nov 1995
Decision
132d
Days
Class 1
Risk

K953345 is an FDA 510(k) clearance for the GENESIS. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Tecan U.S., Inc. (Research Triangle Park, US). The FDA issued a Cleared decision on November 21, 1995 after a review of 132 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 Tecan U.S., Inc. devices

FDA 510(k) Submission Details - K953345

510(k) Number K953345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1995
Decision Date November 21, 1995
Days to Decision 132 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
44d slower than avg
Panel avg: 88d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

JQW Device Classification - Class 1, General Controls

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 84
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