Cleared Traditional

HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT (K960029) - FDA 510(k) Clearance

Class I Chemistry device.

K960029 · Morax · Chemistry device
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Jul 1996
Decision
197d
Days
Class 1
Risk

K960029 is an FDA 510(k) clearance for the HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT. Classified as Electrophoretic, Protein Fractionation (product code CEF), Class I - General Controls.

Submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on July 17, 1996 after a review of 197 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1630 - 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 Morax devices

Submission Details

510(k) Number K960029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1996
Decision Date July 17, 1996
Days to Decision 197 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
109d slower than avg
Panel avg: 88d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEF Electrophoretic, Protein Fractionation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1630
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 - CEF Electrophoretic, Protein Fractionation

All 28
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