Cleared Traditional

K933088 - PLATO 3000

K933088 is an FDA 510(k) clearance for PLATO 3000, manufactured by Rosys, Inc.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K933088 · Rosys, Inc. · Chemistry device
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Feb 1994
Decision
247d
Days
Class 1
Risk

K933088 is an FDA 510(k) clearance for the PLATO 3000. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Rosys, Inc. (Wilmington, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 247 days - an extended review cycle.

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 Rosys, Inc. devices

FDA 510(k) Submission Details - K933088

510(k) Number K933088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1993
Decision Date February 25, 1994
Days to Decision 247 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
159d slower than avg
Panel avg: 88d · This submission: 247d
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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