Cleared Traditional

K951536 - HYDRAGEL PROTEIN(E) KIT

K951536 is an FDA 510(k) clearance for HYDRAGEL PROTEIN(E) KIT, manufactured by Sebia. The device is a Class 1 Chemistry device with product code CEF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K951536 · Sebia · Chemistry device
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Jun 1995
Decision
88d
Days
Class 1
Risk

K951536 is an FDA 510(k) clearance for the HYDRAGEL PROTEIN(E) KIT. Classified as Electrophoretic, Protein Fractionation (product code CEF), Class I - General Controls.

Submitted by Sebia (Chelsea, US). The FDA issued a Cleared decision on June 30, 1995 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sebia devices

FDA 510(k) Submission Details - K951536

510(k) Number K951536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1995
Decision Date June 30, 1995
Days to Decision 88 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 88d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

CEF Device Classification - Class 1, General Controls

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 27
Devices cleared under the same product code (CEF) and FDA review panel - the closest regulatory comparables to K951536.
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