Cleared Traditional

I.D. AND SEAKEM GTG AGAROSES (K940037) - FDA 510(k) Clearance

Class I Chemistry device.

K940037 · Fmc Corp. · Chemistry device
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Feb 1995
Decision
416d
Days
Class 1
Risk

K940037 is an FDA 510(k) clearance for the I.D. AND SEAKEM GTG AGAROSES. Classified as Support Gels (product code JZR), Class I - General Controls.

Submitted by Fmc Corp. (Washington, US). The FDA issued a Cleared decision on February 24, 1995 after a review of 416 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.4900 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Fmc Corp. devices

Submission Details

510(k) Number K940037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1994
Decision Date February 24, 1995
Days to Decision 416 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
328d slower than avg
Panel avg: 88d · This submission: 416d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JZR Support Gels
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.4900
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.