Cleared Traditional

GENESIS RMP (K963268) - FDA 510(k) Clearance

Class I Chemistry device.

K963268 · Tecan U.S., Inc. · Chemistry device
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Mar 1997
Decision
210d
Days
Class 1
Risk

K963268 is an FDA 510(k) clearance for the GENESIS RMP. Classified as Microtitrator, For Clinical Use (product code JRA), Class I - General Controls.

Submitted by Tecan U.S., Inc. (Research Triangle Park, US). The FDA issued a Cleared decision on March 18, 1997 after a review of 210 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2680 - 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

Submission Details

510(k) Number K963268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1996
Decision Date March 18, 1997
Days to Decision 210 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
122d slower than avg
Panel avg: 88d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JRA Microtitrator, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2680
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.